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Introduction: Dalbavancin is a semisynthetic lipoglycopeptide long-acting antibiotic approved for the treatment of acute bacterial skin and skin structure infections (ABSSSIs). Its features can be useful in the current healthcare scenario characterized by the shortage of available hospital beds. Materials methods and results: We implemented several actions in order to optimize the use of dalbavancin allowing an improvement strategy both from the healthcare system and the patient's perspective in two hospital settings. In the Emergency Department we hospitalized only patients who met the clinical criteria and not the logistic criteria (i.e., the need for antibiotic therapy infusion). During the years 2017-2023, this strategy was applied in 40 cases, thus avoiding 40 hospitalizations for a total saving of 280 days of hospitalization.In the Internal Medicine ward and surgery department when there was no longer any need for hospitalization, we discharged the patient as early as possible. During the years 2017-2023, this strategy was applied in 189 cases, saving at least 1,134 days of hospitalization. The outcome of the treated patients was favorable in 228 out of 229 patients (99.5%). Conclusions: Our experience using dalbavancin in ABSSSI has been very satisfactory overall. The efficacy was close to 100%. Minor adverse events of slight severity occurred rarely. At the same time, this strategy allowed a more efficient allocation of hospital beds. Dalbavancin presents an ideal pharmacodynamic/pharmacokinetic profile for the management of ABSSSI especially in settings where shortage of hospital beds is critical.

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Introduction: The therapeutic approach to the patient with acute bacterial skin and skin structure infection (ABSSSI) and complicated infections often involves the early transition from intravenous to oral therapy (early switch) or early discharge. Our study aimed to evaluate sustainable and innovative care models that can be transferred to community healthcare and the economic impact of dalbavancin therapy vs Standard of Care (SoC) therapy for the treatment of ABSSSI and other Gram-positive infections including those by multidrug-resistant organisms. We also described the organization of an infectious disease network that allows optimizing the treatment of ABSSSI and other complex infections with dalbavancin. Materials and Methods: We retrospectively studied all patients treated with dalbavancin in the University Hospital "S. Anna" of Ferrara, Italy, between November 2016 and December 2022. The clinical information of each patient was collected from the hospital's SAP database and used to evaluate the impact of dalbavancin in early discharge with reduction of length of stay promoting dehospitalization and in improving adherence to antibiotic therapy. Results: A total of 287 patients (165 males and 122 females) were included in the study of which 62 were treated with dalbavancin. In 13/62 patients dalbavancin was administered in a single dose at the completion of therapy to facilitate early discharge. Assuming a 12-day hospitalization required for the treatment of ABSSSI or to complete the treatment of osteomyelitis or spondilodiscitis, the treatment with dalbavancin results in a cost reduction of more than €3,200 per single patient compared to SoC (dancomycin, linezolid or vancomycin). Conclusions: Dalbavancin has proven to be a valid therapeutic aid in the organization of a territorial infectious disease network given its prolonged action, which allows the dehospitalization with management of even patients with complex infections in outpatient parenteral antimicrobial therapy.

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Acute bacterial skin and skin structure infections (ABSSSIs) represent a common and costly healthcare burden, accounting for millions of annual infections and billions of dollars in healthcare expenditures. Dalbavancin is a long-acting glycopeptide antibiotic that has demonstrated efficacy and safety in the treatment of ABSSSIs. This review article will examine the efficacy of dalbavancin and focus on its impact on the hospital length of stay and costs associated with management of these infections.

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BACKGROUND: A pathway for the treatment of acute bacterial skin and skin structure infections (ABSSSI) with a single intravenous (IV) dose of dalbavancin was previously shown to reduce hospital admissions and shorten inpatient length of stay (LOS). OBJECTIVES: To describe pathway implementation at the emergency department (ED) and evaluate cost-effectiveness of a single-dose dalbavancin administered to ED patients who would otherwise be hospitalized to receive usual care with multidose IV antibiotics. METHODS: The dalbavancin pathway was previously implemented at 11 U.S. EDs (doi:10.1111/acem.14258). Patients with ABSSSI, without an unstable comorbidity or infection complication requiring complex management, were treated with a single dose of dalbavancin. At the emergency physicians' discretion, patients were either discharged and received outpatient follow-up or were hospitalized for continued management. A decision analytic cost-effectiveness model was developed from the U.S. healthcare's perspective to evaluate costs associated with the dalbavancin pathway compared with inpatient usual care. Costs (2021 USD) were modeled over a 14-day horizon and included ED visits, drug costs, inpatient stay, and physician visits. One-way and probabilistic sensitivity analyses examined input parameter uncertainty. RESULTS: Driven largely by the per diem inpatient cost and LOS for usual care, the dalbavancin pathway was associated with savings of $5133.20 per patient and $1211.57 per hospitalization day avoided, compared with inpatient usual care. The results remained robust in sensitivity and scenario analyses. CONCLUSION: The new single-dose dalbavancin ED pathway for ABSSSI treatment, which was previously implemented at 11 U.S. EDs, offers robust cost savings compared to inpatient usual care.

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OBJECTIVES: We report the use of IV dalbavancin in Canadian patients using data captured by the national CLEAR registry. METHODS: The CLEAR registry uses the web-based data management program, REDCap™ (online survey https://rcsurvey.radyfhs.umanitoba.ca/surveys/?s=TPMWJX98HL) to facilitate clinicians entering details associated with their clinical experiences using IV dalbavancin. RESULTS: Data were available for 40 patients. The most common infections treated were acute bacterial skin and skin structure infection (ABSSSI) (62.5% of patients), bone/joint infection (22.5%), bloodstream/vascular infection (7.5%) and endocarditis (5.0%). Dalbavancin was used as directed (75.0%) and empiric therapy (25.0%). MRSA was the most common identified pathogen (70.0%). Dalbavancin was used both in outpatient (e.g., emergency department) (65.0%), and inpatient treatment settings (e.g., hospital ward) (35.0%). Dalbavancin was used due to the convenience of a single dose treatment (77.5%) as well as to facilitate hospital discharge (7.5%). Dalbavancin was primarily used alone (90.0%), and most commonly using a single 1500 mg dose (77.5%). Microbiological success (pathogen eradicated or presumed eradicated) occurred in 88.2% of known cases, while clinical success (cure and/or improvement) occurred in 93.3% of known cases. No adverse events were reported. CONCLUSIONS: In Canada, IV dalbavancin is used as both directed and empiric therapy to treat ABSSSI as well as off-label (bone/joint, bacteremia/vascular, endocarditis, device-related) infections. It is used in both outpatient and inpatient settings due primarily to its convenience as a single-dose treatment regimen and to facilitate early hospital discharge. Dalbavancin use is associated with high microbiological and clinical cure rates along with an excellent safety profile.

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BACKGROUND: Many patients with cellulitis are treated with oral antibiotics as outpatients, but some require hospital admission for intravenous antibiotics. During the coronavirus disease 2019 pandemic, Betsi Cadwaladr University Health Board in Wales approved use of dalbavancin as first-line intravenous antibiotic from April to December 2020 to facilitate early discharge and prevent hospital admission. OBJECTIVES: To report cost savings and admission avoidance through first-line intravenous use of dalbavancin for cellulitis in one health board in Wales. PATIENTS AND METHODS: Patients with cellulitis who presented to the emergency department or medical assessment unit at Betsi Cadwaladr University Health Board's two hospitals between April and December 2020 were identified for treatment with dalbavancin, because they had not responded to oral antibiotics or their initial presentation warranted intravenous antibiotics. Patients received 1500 mg dalbavancin by intravenous infusion according to prescribing information and were sent home without being admitted. Outcomes were admission within 30 d of dalbavancin and cost savings from avoiding admission. RESULTS: 31 patients were treated with dalbavancin for cellulitis in the emergency department or medical assessment unit. No patient was admitted within 30 d of receiving dalbavancin. Use of dalbavancin is estimated to have saved 248 bed-days over the study period, with an estimated saving of $120,444.23 based on avoidance of admission. The cost of dalbavancin for these 31 patients was $69,959.08, giving an overall cost saving of $50,485.15 ($1529.95 per patient). CONCLUSIONS: Prescribing dalbavancin as first-line intravenous antibiotic for cellulitis prevents admission, saving bed-days and admission-related costs.

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Acute Bacterial Skin and Skin Structure Infections (ABSSSI) are marked by substantial morbidity, frequent need for hospitalization, and long courses of intravenous antibiotic therapy. Herein, we report four cases of pediatric patients admitted for ABSSSI and managed with a combination antibiotic regimen incorporating dalbavancin: a second-generation lipoglycopeptide active against Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. In our experience, particularly in a setting with a high methicillin-resistance rate, dalbavancin demonstrated safety and efficacy, simplifying ABSSSI management in childhood. Its prolonged half-life enables a single-dose administration regimen, offering potential solutions to numerous challenges encountered in pediatric care, such as extended hospital stays, difficulties in securing and maintaining vascular access, lack of pediatric-specific drug indications, and limited availability of suitable oral formulations.

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OBJECTIVES: To retrospectively describe the patterns of use of dalbavancin for treating infections in diabetic patients in Italian and Spanish standard clinical practice. METHODS: DALBADIA [NCT04959799] was a multicentre, observational, retrospective cohort study, conducted in Italy and Spain. The study enrolled 97 adults with type 1 or 2 diabetes mellitus, treated with dalbavancin as per standard clinical practice for a Gram-positive bacterial infection or the Gram-positive component of a mixed infection. RESULTS: Dalbavancin was used to treat cellulitis (18/92 patients, 19.6%), followed by prosthetic joint infection (14 patients, 15.2%), endocarditis (13 patients, 14.1%), and primary bacteraemia (10 patients, 10.9%); 78/92 (84.8%) patients had Gram-positive infections only, and 14 (15.2%) had mixed infections. The most frequently isolated microorganisms were Staphylococcus aureus in 43 (55.8% of the patients with microbial isolation), 25.6% of which methicillin-resistant; Staphylococcus epidermidis in 13 (16.9%), 53.8% of which methicillin-resistant; Enterococcus faecalis in 11 (14.3%). The main reason for the dalbavancin choice was the intent to simplify the antibiotic regimen (81.5% of cases). A multidisciplinary team participated in the treatment choice process for 53 (57.6%) patients. Dalbavancin was given as first-line antibiotic in 34 (37.0%) patients and administered as one infusion in 32 (34.8%), and as two infusions in 39 (42.4%). In total, 57/62 (91.9%) eligible patients with available assessment were judged clinically cured or improved at the end of observation. CONCLUSION: In clinical practice, dalbavancin was used in diabetic patients to treat ABSSSIs and other difficult-to-treat infections with a favourable safety profile and a high rate of positive clinical responses.

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Introduction: The increasing emergence of bacterial strains with new resistance determinants has become a threat to current antibiotic therapies in recent years. This has prompted research for innovative options with improved efficacy and safety profiles: long-acting glycopeptides, such as dalbavancin and oritavancin, are currently approved for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Their efficacy, microbiological profile, and ease of administration may provide an answer to this challenge, as well as reducing length of stay and hospital costs. This narrative review aims to explore the current evidence on the real-word use of dalbavancin and oritavancin, in labelled and off-label indications in clinical practice. Methods: A PubMed library database search with no time limits was performed using the following terms: long-acting antibiotics, dalbavancin, oritavancin. Discussion: Registration studies confirmed non-inferiority of long-acting glycopeptides to standard of care in ABSSSI (dalbavancin DISCOVER 1 and 2: 79.7% clinical success in the dalbavancin group and 79.8% in the vancomycin-linezolid group; oritavancin SOLO I: 82,3% clinical success in the oritavancin group versus 78,9% for the vancomycin group; SOLO II: 80,1% clinical success versus 82,9%). Large cohorts have confirmed similar success rates in ABSSSI treatment in real-world practice. Evidence for off-label indications is still rather scarce but promising, especially in bone and joint infections therapy for both dalbavancin and oritavancin, and infective endocarditis for dalbavancin. Moreover, these drugs may have their place in non-adherent patients, in setting of addition or difficult access to healthcare. Another potential use of these drugs is in patients with oral intake impairment or reduced gastro-intestinal absorption. However, the low penetration in cerebrospinal fluid of dalbavancin and the unfavourable outcomes in the only case report of oritavancin treatment in human meningitis despite encouraging animal models would seem to make these molecules unsuitable for central nervous system infection therapy. Most of the available evidence is based on small retrospective cohorts, so robust prospective studies investigating off-label indications are needed.

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The extensive use of fluoroquinolones has been consequently accompanied by the emergence of bacterial resistance, which triggers the necessity to discover new compounds. Delafloxacin is a brand-new anionic non-zwitterionic fluoroquinolone with some structural particularities that give it attractive proprieties: high activity under acidic conditions, greater in vitro activity against Gram-positive bacteria-even those showing resistance to currently-used fluoroquinolones-and nearly equivalent affinity for both type-II topoisomerases (i.e., DNA gyrase and topoisomerase IV). During phases II and III clinical trials, delafloxacin showed non-inferiority compared to standard-of-care therapy in the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia, which resulted in its approval in 2017 by the Food and Drug Administration for indications. Thanks to its overall good tolerance, its broad-spectrum in vitro activity, and its ease of use, it could represent a promising molecule for the treatment of bacterial infections.

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INTRODUCTION: Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) are a common reason of Emergency Department (ED) access and account for a considerable number of hospital admissions and a high economic burden for the healthcare system. The long-acting lipoglycopeptides (LALs) allow for an outpatient management of subjects with ABSSSIs, still requiring parenteral therapy, but who do not need hospitalization. AREAS COVERED: The following topics were addressed: i) microbiological activity, efficacy, and safety of dalbavancin, ii) critical steps for the management of ABSSSIs in the ED (decision to hospitalize, risk of bacteremia and infection recurrence), iii) feasibility of direct/early discharge from the ED and potential advantage of dalbavancin. EXPERT OPINION: Authors' expert opinion was focused on drawing the profiles of patients who could benefit most from an antimicrobial therapy with dalbavancin in the ED and positioning this drug as a direct or early discharge strategy from the ED in order to avoid hospitalization and its complications. We have provided a therapeutic and diagnostic algorithm based on evidence from the literature and authors' expert opinion and suggest the use of dalbavancin in patients with ABSSSIs who are not eligible for oral therapies or Outpatient Parenteral Antibiotic Therapy (OPAT) programs and who would have otherwise been hospitalized only for antibiotic therapy.

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Kimyrsa is a new formulation (NF) of the original formulation of oritavancin ([OF] Orbactiv). Comparatively, the obvious benefit with this product is the shortened infusion time and flexibility with solution compatibility, but otherwise maintains a similar pharmacokinetic and microbiologic profile. At present, the NF lacks significant real-world experience relative to other available lipoglycopeptides and thus its place in therapy remains difficult to predict but would not be expected to be significantly different than its OF.

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OBJECTIVES: Acute bacterial skin and skin-structure infections (ABSSSIs) are a common source of morbidity in both the community and hospital settings. The current standard of care (SoC) requires multiple-dose intravenous (IV) regimens, which are associated with high hospitalisation rates, concomitant event risks and costs. Dalbavancin is a lipoglycopeptide, long-acting antibiotic that is effective against Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA). Dalbavancin allows treatment of ABSSSIs with a single-shot IV administration or once weekly for 2 weeks, enabling clinicians to treat patients in an outpatient setting or to shorten the length of hospital stay. METHODS: This multicentre, observational, retrospective study compared hospitalised patients who received dalbavancin and patients treated with the three most used IV antibiotics of the same or similar class: vancomycin, teicoplanin and daptomycin. The primary outcome was the time to discharge after starting the study antibiotics. RESULTS: The primary endpoint, time to discharge from the study therapy start, was measured for both groups: the median number of days was 6.5 in the dalbavancin group vs. 11.0 days in the SoC group. Moreover, in subpopulations of patients receiving one or more concomitant antibiotics active for Gram-positives, MRSA and patients with the most prevalent comorbidity (i.e., diabetes), the advantage of dalbavancin in terms of length of stay was confirmed, with a halved time to discharge or more. Safety data on dalbavancin were consistent with data collected in clinical trials. No serious adverse drug reactions related to dalbavancin were reported and most of them were classified as skin and subcutaneous tissue disorders. One serious ADR was reported for daptomycin. CONCLUSIONS: Although the analysis was only descriptive, it can be concluded that dalbavancin may enable a remarkable reduction in length of hospital stay, also confirming the clinical effectiveness and good safety profile demonstrated in clinical trials in a real-world setting.

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INTRODUCTION: Acute bacterial skin and skin structure infections (ABSSSIs) are a subtype of skin and soft tissue infections (SSTI), usually sustained by Gram-positive bacteria, whose incidence is high among children. ABSSSIs are responsible for a considerable number of hospitalizations. Moreover, as multidrug resistant (MDR) pathogens become widespread, the pediatric category seems burdened with an increased risk of resistance and treatment failure. AREAS COVERED: To obtain a view on the status of the field, we describe the clinical, epidemiological, and microbiological aspects of ABSSSI in children. Old and new treatment options were critically revised with a focus on the pharmacological characteristics of dalbavancin. Evidence on the use of dalbavancin in children was collected, analyzed, and summarized. EXPERT OPINION: Many of the therapeutic options available at the moment are characterized by the need for hospitalization or repeated intravenous infusions, safety issues, possible drug-drug interactions, and reduced efficacy on MDRs. Dalbavancin, the first long-acting molecule with strong activity against methicillin-resistant and also many vancomycin-resistant pathogens represents a game changer for adult ABSSSI. In pediatric settings, the available literature is still limited, but a growing body of evidence supports dalbavancin use in children with ABSSSI, demonstrating this drug to be safe and highly efficacious.

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INTRODUCTION: Omadacycline is approved for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and soft tissue infection (ABSSSI). The integration of newer agents into clinical use involves understanding the nuances of clinical decision-making. This review will provide an in-depth focus on omadacycline in clinical practice. AREAS COVERED: Literature review of omadacycline utilizing PubMed was performed to provide a comprehensive evaluation of omadacycline pharmacology, microbiology, registrational Phase 3 clinical trials, and post-marketing clinical studies. In addition, the immunomodulatory and other attributes of tetracycline class of antibiotics, of which omadacycline is a member, are reviewed, introducing the concept of antibiotic selection with attention to the bacterial pathogen and human host relationship. EXPERT OPINION: Omadacycline builds upon the favorable attributes of tetracycline antibiotics and provides very reliable empiric coverage for both Staphylococcus aureus and Streptococcus spp. Clinicians require a more robust understanding of antibiotics, including omadacycline, in order to optimize patient outcomes, streamline care, and reduce medical costs.

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INTRODUCTION: Dalbavancin is a second-generation lipoglycopeptide approved since 2014 to treat acute bacterial skin and skin-structure infections (ABSSSI). Dalbavancin is characterized by Gram-positive activity and novel pharmacokinetic properties allowing prolonged terminal half-life andonce weekly dosing . A good safety profile was reported in clinical trials . AREAS COVERED: Dalbavancin safety and tolerability from trials and post-marketing studies were reviewed. While most reports included predominantly ABSSSI, two clinical trials and recent observational studies have explored the use of dalbavancin for off-label indications, mainly including bloodstream and osteoarticular infections. EXPERT OPINION: The occurrence of drug-related adverse effects (AE) was similar between dalbavancin and comparators in clinical trials enrolling patients with ABSSSI. Most common AE included gastrointestinal symptoms, infusion reaction, and hypersensitivity. Low rates of drug discontinuation and serious AE were reported across studies. In the past 5 years, several observational studies have reported safety data on the use of dalbavancin, confirming its favorable safety profile. Nevertheless, data from dalbavancin off-label use, often derived from prolonged (>2 weeks) treatments with variable dosing regimens, were mainly retrospective and lacked comparators. Further research is required to allow a reliable analysis of short- and long-term dalbavancin-related AE in non-ABSSSI.

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Contezolid (MRX-I, Youxitai) is an oral oxazolidinone drug being developed by MicuRx Pharmaceutical Co., Ltd., Shanghai, China. It was approved by China's National Medical Products Administration (NMPA) in June 2021, attaining its first approval for the treatment of complicated skin and soft tissue infections (cSSTIs). It is also under clinical development for acute bacterial skin and skin structure infections (ABSSSIs) in the U.S. after receiving qualified infectious disease product (QIDP) classification and fast track status by U.S. Food and Drug Administration (FDA) in September 2018. Contezolid is effective against a broad range of Gram-positive bacteria including activity against methicillin-resistant Staphylococcus aureus (MRSA), penicillin-resistant Streptococcus pneumoniae and vancomycin-resistant Enterococci (VRE). It provides a major benefit over the most popular drug of its class, linezolid (Zyvox), by offering an improved safety profile and minimal effects concerning myelosuppression and monoamine oxidase (MAO) inhibition, two independent adverse events limiting linezolid use in the clinic. The recommended dosage regimen of contezolid is 800 mg every 12 hours for 7-14 days with regular food intake and it can be extended if required. At the mentioned dose under fed conditions, satisfactory efficacy against MRSA with a 90%; or higher cumulative fraction of response and probability of target attainment was achieved. Additionally, contezolid also exhibits activity against Mycobacterium tuberculosis and Mycobacterium abscessus.

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Staphylococcus aureus remains an important human pathogen of concern, with mortality rates surpassing 30% in the case of severe systemic infections. Distinguishing methicillin-susceptible S. aureus from methicillin-resistant S. aureus (MRSA) is fundamental for therapeutic choices. A crucial emerging concept in the treatment of acute bacterial skin and skin structure infections is the availability of various approved agents with anti-MRSA activity, which allow a personalized approach based on the characteristics of any given patient while at the same time remaining in line with high certainty efficacy evidence from large randomized controlled trials. Regarding the treatment of S. aureus bloodstream infections (BSI), interesting aspects that may become relevant in the near future are the presence of both old and novel agents in phase-2 or phase-3 of clinical development for this indication, and the pressing need for high certainty evidence to guide the possible use of combination therapy in specific categories or phenotypes of patients with complicated MRSA BSI.

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The antibiotic dalbavancin is approved for intravenous treatment of adults with acute bacterial skin and skin structure infections. This study aimed to observe the use, effectiveness, and safety of dalbavancin in clinical practice in Germany. It was a multicentre, prospective, and retrospective registry and consecutively enrolled patients treated with dalbavancin. Each patient was observed from the first to the last dose of dalbavancin, with a 30-day follow-up. Patient inclusion was planned for 2 years, but was terminated early due to low recruitment. All analyses were descriptive. Between November 2018 and December 2019, nine patients were enrolled. Only three patients were treated for the approved indication. Outcome was assessed by the physicians as 'success' in five (55.6%) patients, 'failure' in one (11.1%) patient, and non-evaluable in three (33.3%) patients. Although the success rate of dalbavancin was lower than reported previously, this may be due to the severity of underlying infections and patients' high Charlson Comorbidity Index. None of the two reported adverse events were considered related to dalbavancin. These findings were in line with real-world data for dalbavancin from other countries, supporting the drug's positive benefit-risk profile and suggesting frequent off-label use in German routine practice.

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Background Antimicrobial resistance by bacteria poses a substantial threat to the success in the treatment of acute bacterial skin and skin structure infections (ABSSSI). Levonadifloxacin is a novel benzoquinolizine subclass of quinolone which has a broad spectrum of activity, available in both oral and intravenous formulations for the treatment of skin structure infections caused by Gram-positive pathogens including methicillin-resistant Staphylococcus aureus (MRSA). Patients and methods This prescription event monitoring study captured data of 227 patients receiving levonadifloxacin (oral and/or IV) in a real-world setting to assess the safety and efficacy in the treatment of ABSSSI. Study outcomes were a clinical and microbial success at the end of therapy and safety was assessed based on adverse events reported. Results One hundred and forty patients received IV levonadifloxacin therapy, 76 patients received oral alalevonadifloxacin, and 11 received IV followed by oral therapy. The mean duration of therapy was 7.3 days. Out of 227 patients, MRSA isolates were identified in 79 patients. Clinical success rates with oral, IV, and IV followed by oral levonadifloxacin therapy were 97.3%, 97.8%, and 100% respectively. The overall microbial success rate was 99.2% and only two patients reported two adverse events. Conclusions The excellent safety and efficacy profile of levonadifloxacin on oral and/or intravenous therapy, makes it a desirable treatment modality for management of ABSSSI. Unique features of levonadifloxacin such as availability of both IV and oral form, minimal drug-drug interactions, exemption from dosage adjustment in renal and hepatic impaired patients and a broad spectrum of coverage, makes it a suitable agent meeting several unmet clinical needs in contemporary patients.