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Capivasertib: First Approval. Capivasertib:首次批准。
IF 11.5 1区 医学
Drugs Pub Date : 2024-03-01 DOI: 10.1007/s40265-024-01998-6
Matt Shirley
{"title":"Capivasertib: First Approval.","authors":"Matt Shirley","doi":"10.1007/s40265-024-01998-6","DOIUrl":"10.1007/s40265-024-01998-6","url":null,"abstract":"<p><p>Capivasertib (Truqap™) is an orally available, small-molecule pan-AKT inhibitor being developed by AstraZeneca for the treatment of various cancers, including breast and prostate cancers. Capivasertib received its first approval, in the USA, in November 2023 for use in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. Capivasertib is also under regulatory review for HR-positive, HER2-negative breast cancer in the EU and several other countries, and in phase III clinical development for use (in combination with other anti-cancer agents) in the treatment of triple-negative breast cancer, castration-resistant prostate cancer, and hormone-sensitive prostate cancer. This article summarizes the milestones in the development of capivasertib leading to this first approval for HR-positive, HER2-negative, locally advanced or metastatic breast cancer.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":null,"pages":null},"PeriodicalIF":11.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139930559","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Correction: Zilucoplan: First Approval. 更正:Zilucoplan:首次批准。
IF 11.5 1区 医学
Drugs Pub Date : 2024-03-01 Epub Date: 2024-03-19 DOI: 10.1007/s40265-024-02019-2
Matt Shirley
{"title":"Correction: Zilucoplan: First Approval.","authors":"Matt Shirley","doi":"10.1007/s40265-024-02019-2","DOIUrl":"10.1007/s40265-024-02019-2","url":null,"abstract":"","PeriodicalId":11482,"journal":{"name":"Drugs","volume":null,"pages":null},"PeriodicalIF":11.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10982084/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140157779","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Nirogacestat: First Approval. 尼罗加司他首次批准。
IF 11.5 1区 医学
Drugs Pub Date : 2024-03-01 DOI: 10.1007/s40265-024-02002-x
Susan J Keam
{"title":"Nirogacestat: First Approval.","authors":"Susan J Keam","doi":"10.1007/s40265-024-02002-x","DOIUrl":"10.1007/s40265-024-02002-x","url":null,"abstract":"<p><p>Nirogacestat (OGSIVEO™) is an oral, selective, reversible, small molecule γ-secretase inhibitor developed by SpringWorks Therapeutics, Inc. γ-Secretase is a multi-subunit protease complex that cleaves multiple transmembrane protein complexes, including Notch and membrane-bound B-cell maturation antigen (BCMA). Inhibition of γ-secretase may result in growth inhibition of tumour cells overexpressing Notch, and preservation of membrane-bound BCMA may increase target density for BCMA-targeted therapy. In November 2023, nirogacestat was approved in the USA for use in adult patients with progressing desmoid tumours who require systemic treatment. This article summarizes the milestones in the development of nirogacestat leading to this first approval for the systemic treatment of desmoid tumours.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":null,"pages":null},"PeriodicalIF":11.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139971376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Drugs Targeting CD20 in Multiple Sclerosis: Pharmacology, Efficacy, Safety, and Tolerability. 多发性硬化症的 CD20 靶向药物:药理学、疗效、安全性和耐受性。
IF 11.5 1区 医学
Drugs Pub Date : 2024-03-01 Epub Date: 2024-03-14 DOI: 10.1007/s40265-024-02011-w
Alise K Carlson, Moein Amin, Jeffrey A Cohen
{"title":"Drugs Targeting CD20 in Multiple Sclerosis: Pharmacology, Efficacy, Safety, and Tolerability.","authors":"Alise K Carlson, Moein Amin, Jeffrey A Cohen","doi":"10.1007/s40265-024-02011-w","DOIUrl":"10.1007/s40265-024-02011-w","url":null,"abstract":"<p><p>Currently, there are four monoclonal antibodies (mAbs) that target the cluster of differentiation (CD) 20 receptor available to treat multiple sclerosis (MS): rituximab, ocrelizumab, ofatumumab, and ublituximab. B-cell depletion therapy has changed the therapeutic landscape of MS through robust efficacy on clinical manifestations and MRI lesion activity, and the currently available anti-CD20 mAb therapies for use in MS are a cornerstone of highly effective disease-modifying treatment. Ocrelizumab is currently the only therapy with regulatory approval for primary progressive MS. There are currently few data regarding the relative efficacy of these therapies, though several clinical trials are ongoing. Safety concerns applicable to this class of therapeutics relate primarily to immunogenicity and mechanism of action, and include infusion-related or injection-related reactions, development of hypogammaglobulinemia (leading to increased infection and malignancy risk), and decreased vaccine response. Exploration of alternative dose/dosing schedules might be an effective strategy for mitigating these risks. Future development of biosimilar medications might make these therapies more readily available. Although anti-CD20 mAb therapies have led to significant improvements in disease outcomes, CNS-penetrant therapies are still needed to more effectively address the compartmentalized inflammation thought to play an important role in disability progression.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":null,"pages":null},"PeriodicalIF":11.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10982103/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140119078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Lebrikizumab: First Approval. Lebrikizumab:首次批准。
IF 11.5 1区 医学
Drugs Pub Date : 2024-03-01 DOI: 10.1007/s40265-024-02000-z
Susan J Keam
{"title":"Lebrikizumab: First Approval.","authors":"Susan J Keam","doi":"10.1007/s40265-024-02000-z","DOIUrl":"10.1007/s40265-024-02000-z","url":null,"abstract":"<p><p>Lebrikizumab (Ebglyss<sup>®</sup>) is a subcutaneous recombinant humanized IgG4 anti-IL-13 monoclonal antibody developed by Almirall S.A. and Eli Lilly and Company for the treatment of atopic dermatitis (AD). In November 2023, lebrikizumab was approved in the EU for the treatment of moderate-to-severe AD in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy. Lebrikizumab was approved for the same indication in the UK in December 2023 and in Japan in January 2024. Lebrikizumab is under regulatory review for the treatment of AD in the USA, Switzerland and Australia. This article summarizes the milestones in the development of lebrikizumab leading to this first approval for AD.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":null,"pages":null},"PeriodicalIF":11.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139930561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Berdazimer Topical Gel, 10.3%: First Approval. Berdazimer 外用凝胶,10.3%:首次批准。
IF 11.5 1区 医学
Drugs Pub Date : 2024-03-01 DOI: 10.1007/s40265-024-02012-9
Susan J Keam
{"title":"Berdazimer Topical Gel, 10.3%: First Approval.","authors":"Susan J Keam","doi":"10.1007/s40265-024-02012-9","DOIUrl":"10.1007/s40265-024-02012-9","url":null,"abstract":"<p><p>Berdazimer topical gel, 10.3% (ZELSUVMI™) is a nitric oxide (NO) releasing topical gel developed by Novan Inc. (a Ligand Pharmaceuticals company) for the treatment of molluscum contagiosum (MC). Novan has used their proprietary NO-based technology platform (NITRICIL™), which stores gaseous NO species on large polymers, in the development of berdazimer topical gel, 10.3%. In January 2024, berdazimer topical gel, 10.3% was approved for the topical treatment of MC in adult and paediatric patients 1 year of age and older in the USA. This article summarizes the milestones in the development of berdazimer topical gel, 10.3% leading to this first approval for the treatment of MC.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":null,"pages":null},"PeriodicalIF":11.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139971375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Correction: Lumasiran: A Review in Primary Hyperoxaluria Type 1. 更正:卢马西兰:原发性高草酸尿症 1 型综述。
IF 11.5 1区 医学
Drugs Pub Date : 2024-03-01 Epub Date: 2024-03-15 DOI: 10.1007/s40265-024-02014-7
Connie Kang
{"title":"Correction: Lumasiran: A Review in Primary Hyperoxaluria Type 1.","authors":"Connie Kang","doi":"10.1007/s40265-024-02014-7","DOIUrl":"10.1007/s40265-024-02014-7","url":null,"abstract":"","PeriodicalId":11482,"journal":{"name":"Drugs","volume":null,"pages":null},"PeriodicalIF":11.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10982085/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140136616","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Vonoprazan: A Review in Helicobacter pylori Infection. 沃诺普拉赞:幽门螺杆菌感染综述
IF 11.5 1区 医学
Drugs Pub Date : 2024-03-01 Epub Date: 2024-02-23 DOI: 10.1007/s40265-023-01991-5
Matt Shirley
{"title":"Vonoprazan: A Review in Helicobacter pylori Infection.","authors":"Matt Shirley","doi":"10.1007/s40265-023-01991-5","DOIUrl":"10.1007/s40265-023-01991-5","url":null,"abstract":"<p><p>Treatment for the eradication of Helicobacter pylori infection, a leading cause of peptic ulcer disease and an important risk factor for gastric cancer and mucosa-associated lymphoid tissue lymphoma, is indicated whenever infection is identified. However, treatment success rates with current guideline-recommended proton-pump inhibitor (PPI)-based regimens remain suboptimal, with one potential factor associated with treatment failure being inadequate acid suppression. Vonoprazan (Voquezna<sup>®</sup>) is a first-in-class potassium-competitive acid blocker with the potential to provide potent and sustained acid suppression. Following clinical trials conducted mainly in Asia (supported by post-marketing experience from Asia) and the phase III PHALCON-HP trial conducted in the USA and Europe, vonoprazan is now approved in the USA for use in combination with amoxicillin (dual therapy) or amoxicillin and clarithromycin (triple therapy) for the treatment of H. pylori infection in adults. The vonoprazan-based dual and triple therapy regimens were generally well tolerated in PHALCON-HP. In addition, vonoprazan has advantages including a rapid onset of action and no food effect, making vonoprazan-based dual and triple therapy regimens valuable alternatives to standard PPI-based triple therapy in the treatment of H. pylori infection.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":null,"pages":null},"PeriodicalIF":11.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11090951/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139930470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Microencapsulated Benzoyl Peroxide for Rosacea in Context: A Review of the Current Treatment Landscape. 微胶囊过氧化苯甲酰治疗酒渣鼻的背景:当前治疗形势回顾。
IF 11.5 1区 医学
Drugs Pub Date : 2024-03-01 Epub Date: 2024-02-29 DOI: 10.1007/s40265-024-02003-w
Seemal R Desai, Hilary Baldwin, James Q Del Rosso, Richard L Gallo, Neal Bhatia, Julie C Harper, Jean Philippe York, Linda Stein Gold
{"title":"Microencapsulated Benzoyl Peroxide for Rosacea in Context: A Review of the Current Treatment Landscape.","authors":"Seemal R Desai, Hilary Baldwin, James Q Del Rosso, Richard L Gallo, Neal Bhatia, Julie C Harper, Jean Philippe York, Linda Stein Gold","doi":"10.1007/s40265-024-02003-w","DOIUrl":"10.1007/s40265-024-02003-w","url":null,"abstract":"<p><p>Rosacea, a chronic skin condition affecting millions of people in the USA, leads to significant social and professional stigmatization. Effective management strategies are crucial to alleviate symptoms and improve patients' quality of life. Encapsulated benzoyl peroxide 5% (E-BPO 5%) is a newly FDA-approved topical treatment for rosacea that shows promise in enhancing therapeutic response and minimizing skin irritation. This review aims to assess the role of recently FDA approved E-BPO 5% in the current treatment landscape for rosacea management, as it is not yet included in clinical guidelines that predominantly rely on older approved therapies. The review focuses on randomized controlled trials conducted in English-speaking adults. It evaluates the efficacy, safety, and tolerability of various US Food and Drug Administration (FDA)-approved agents used for rosacea treatment, including E-BPO cream, metronidazole gel, azelaic acid gel and foam, ivermectin cream, minocycline foam, oral doxycycline, brimonidine gel, and oxymetazoline HCl cream. Existing therapies have been effective in reducing papulopustular lesions and erythema associated with rosacea for many years. E-BPO 5% offers a promising addition to the treatment options due to its microencapsulation technology, which prolongs drug delivery time and aims to improve therapeutic response while minimizing skin irritation. Further research is necessary to determine the exact role of E-BPO 5% in the therapeutic landscape for rosacea. However, based on available evidence, E-BPO 5% shows potential as a valuable treatment option for managing inflammatory lesions of rosacea, and it may offer benefits to patients including: rapid onset of action, demonstrated efficacy by Week 2, excellent tolerability, and sustained long-term results for up to 52 weeks of treatment.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":null,"pages":null},"PeriodicalIF":11.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10982091/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139989634","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
SER-109 (VOWST): A Review in the Prevention of Recurrent Clostridioides difficile Infection. ser-109 (vowst™):预防复发性艰难梭菌感染的综述。
IF 11.5 1区 医学
Drugs Pub Date : 2024-03-01 Epub Date: 2024-03-05 DOI: 10.1007/s40265-024-02006-7
Hannah A Blair
{"title":"SER-109 (VOWST<sup>™</sup>): A Review in the Prevention of Recurrent Clostridioides difficile Infection.","authors":"Hannah A Blair","doi":"10.1007/s40265-024-02006-7","DOIUrl":"10.1007/s40265-024-02006-7","url":null,"abstract":"<p><p>SER-109 (VOWST<sup>™</sup>; fecal microbiota spores, live-brpk) is a live biotherapeutic product indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in patients 18 years of age and older following standard of care (SOC) antibacterial treatment for recurrent CDI. It is a purified bacterial spore suspension sourced from healthy donors. As the first oral faecal microbiota product approved for prevention of recurrent CDI, SER-109 is administered as four capsules once daily for three consecutive days. In a well-designed, placebo-controlled, phase III trial (ECOSPOR III), SER-109 significantly reduced the risk of recurrent CDI at 8 weeks post-treatment, with a durable response seen at 6 months post-treatment. Treatment with SER-109 was also associated with rapid and steady improvement in health-related quality of life compared with placebo. SER-109 was generally well tolerated, with a safety profile similar to that of placebo. The most common adverse events were of mild to moderate severity and generally gastrointestinal in nature. Thus, with the convenience of oral administration and lack of necessity for cold storage, SER-109 is a valuable option for preventing further CDI recurrence in adults following antibacterial treatment for recurrent CDI.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":null,"pages":null},"PeriodicalIF":11.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140027659","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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