Drugs最新文献

{"title":"Recaticimab: First Approval.","authors":"Yvette N Lamb","doi":"10.1007/s40265-025-02199-5","DOIUrl":"10.1007/s40265-025-02199-5","url":null,"abstract":"<p><p>Recaticimab (^®), a humanized monoclonal immunoglobulin G1 antibody that targets proprotein convertase subtilisin/kexin type 9 (PCSK9), is being developed by Suzhou Suncadia Biopharmaceutical for the treatment of hypercholesteremia and mixed dyslipidemia. Recaticimab received its first approval on 8 January 2025 in China, as an adjunct to diet, in combination with statins (with or without other lipid-lowering therapies) in adults with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia who have not achieved their low-density lipoprotein cholesterol (LDL-C) target despite receiving moderate or higher doses of statins, and for use as monotherapy in adults with non-familial hypercholesterolemia and mixed dyslipidemia to reduce LDL-C, total cholesterol, and apolipoprotein B levels. This article summarizes the milestones in the development of recaticimab leading to this first approval for hypercholesterolemia and mixed dyslipidemia.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1067-1072"},"PeriodicalIF":14.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144368695","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}

{"title":"Limertinib: First Approval.","authors":"Arnold Lee","doi":"10.1007/s40265-025-02184-y","DOIUrl":"10.1007/s40265-025-02184-y","url":null,"abstract":"<p><p>Limertinib (Aoyixin) is an orally available, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), which has been developed for the treatment of non-small cell lung cancer (NSCLC). In clinical trials, limertinib demonstrated efficacy in patients who are positive for the T790M gatekeeper mutation. Limertinib received its first approval for the treatment of adults with locally advanced or metastatic NSCLC with disease progression following treatment with an EGFR TKI and are positive for the EGFR T790M mutation in China in January 2025. In April 2025, limertinib was also approved in China for first-line treatment for adult patients with locally advanced or metastatic NSCLC harbouring EGFR exon 19 deletions or exon 21 L858R mutations. This article summarizes the milestones in the development of limertinib leading to this first approval.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1055-1058"},"PeriodicalIF":14.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144474319","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}

{"title":"Novel Potassium Binders in Reduction of Hyperkalemia and Optimization of RAAS Inhibitors Treatment in Patients with Chronic Kidney Disease or Heart Failure: A Systematic Review and Meta-analysis.","authors":"Naya Huang, Yuanwen Xu, Chan Liu, Yuanying Liu, Yanping Fan, Zeyu Li, Dihua Zhang, Haiping Mao, Wei Chen","doi":"10.1007/s40265-025-02198-6","DOIUrl":"10.1007/s40265-025-02198-6","url":null,"abstract":"<p><strong>Background: </strong>Renin-angiotensin-aldosterone system inhibitors (RAASi) and its combination therapy are essential supportive treatments for patients with chronic kidney disease (CKD) and heart failure (HF). Hyperkalemia (HK) is the major safety concern associated with the treatments, which often leads to RAASi dose reduction or discontinuation, thereby compromising cardiovascular protective effects. Although novel potassium binders (NPBs) are recommended by current guidelines for the treatment of HK, systematic evidence is needed to guide their use in RAASi optimization and HK management. A systematic review and meta-analysis was conducted to evaluate the incidence of HK in patients with CKD or HF who received RAASi and the efficacy of NPBs in RAASi optimization.</p><p><strong>Methods: </strong>PubMed, Medline, Embase, and the Cochrane Library were searched from January 1, 2011 to December 31, 2023. Any studies of adult patients with CKD or HF who received RAASi were included in systematic review of HK incidence and risk factors (part 1). Randomized controlled trials (RCTs) of NPBs in patients with CKD or HF were included in meta-analysis on the efficacy of novel potassium binders (NPBs) (part 2). The primary outcome was optimization of RAASi therapy with NPBs. A pooled analysis was conducted in part 1. Network meta-analyses using a random-effects model were performed in part 2.</p><p><strong>Results: </strong>A total of 83 studies (24 with CKD, 54 with HF, and 5 with CKD and HF) were included in part 1 and 8 RCTs (2 with CKD, 4 with HF, and 2 with CKD and HF) were included in part 2. The pooled HK incidence was 10.7% overall at any criteria and in all patients who received RAASi. The highest incidence of HK was observed with the combination of angiotensin converting enzyme inhibitor (ACEi)/angiotensin ii receptor blockers (ARBs)/angiotensin receptor-neprilysin inhibitor (ARNi)+ mineralocorticoid receptor antagonists (MRAs) (24.4%), followed by the triple therapy ACEi/ARB/ARNi+ sodium glucose cotransporter-2 inhibitor (SGLT2i)+MRA (10.9%), and ACEi/ARB/ARNi + SGLT2i (2.2%). Novel potassium binders improved RAASi optimization by 38% compared with placebo (risk ratio, 1.38; 95% CI, 1.16-1.65). Additionally, NPBs decreased the incidence of HK by 28% and reduced the level of potassium by 0.71 mEq/L. The CKD population showed a higher optimization rate than the HF population (84% vs 29%).</p><p><strong>Conclusion: </strong>The RAASi treatment was associated with high prevalence of HK, especially in bigeminal and triple therapy. The NPBs were effective in RAASi optimization and HK management, especially among the CKD population.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1013-1031"},"PeriodicalIF":14.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12321686/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144340020","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}

{"title":"Fitusiran: First Approval.","authors":"Arnold Lee","doi":"10.1007/s40265-025-02203-y","DOIUrl":"10.1007/s40265-025-02203-y","url":null,"abstract":"<p><p>Haemophilia A and B are inherited bleeding disorders caused by mutations in clotting factors. Small interfering RNA therapies may be utilised to restore coagulation by preventing the synthesis of antithrombin. Fitusiran (QFITLIA™) is a small interfering RNA therapy that targets antithrombin, which is being developed by Sanofi for the prophylactic management of haemophilia A and B with or without inhibitors. Fitusiran has the potential to be administered less frequently than other prophylactic treatments for haemophilia. This article summarizes the milestones in the development of fitusiran leading to this first approval for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and paediatric patients aged 12 years and older with haemophilia A or B with or without factor VIII or IX inhibitors.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1073-1077"},"PeriodicalIF":14.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144511686","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}

{"title":"Senaparib: First Approval.","authors":"Arnold Lee","doi":"10.1007/s40265-025-02200-1","DOIUrl":"10.1007/s40265-025-02200-1","url":null,"abstract":"<p><p>Poly(ADP-ribose) polymerase (PARP) inhibitors have demonstrated benefits in progression-free survival for first-line maintenance therapy of ovarian cancer. Senaparib (^®; Sainapali Jiaonang) is a novel PARP inhibitor that potently inhibits PARP1 and PARP2, which is being developed by IMPACT Therapeutics for the treatment of advanced ovarian cancer and small-cell lung cancer. This article summarizes the milestones in the development of senaparib leading to this first approval for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who achieved a complete or partial response to first-line platinum-based chemotherapy.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.4,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144741640","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}

{"title":"Navigating Psoriatic Arthritis: Treatment Pathways and Patient-Specific Strategies for Improved Outcomes.","authors":"Rubén Queiro, José Antonio Pinto-Tasende, Carlos Montilla-Morales","doi":"10.1007/s40265-025-02192-y","DOIUrl":"10.1007/s40265-025-02192-y","url":null,"abstract":"<p><p>Psoriatic arthritis (PsA) is a multifaceted chronic immune-mediated disease characterized by joint, skin, nail and entheseal involvement, affecting approximately 0.3-1% of the global population. In recent years, the treatment options for PsA have expanded from traditional nonsteroidal anti-inflammatory drugs and conventional synthetic disease-modifying antirheumatic drugs (DMARDs) to include biologic DMARDs and targeted synthetic DMARDs. Owing to the heterogeneity of the disease and prevalence of comorbidities, the selection and sequence of treatment are often unclear. In this narrative review, we outline the patient journey from diagnosis through various treatment lines, from conventional therapies to bDMARDS and tsDMARDs, and the considerations for treatment sequencing in patients who do not achieve an adequate response. We examine the factors influencing treatment response, such as disease severity, predominant disease domain, comorbidities, genetic variations, pharmacokinetic and immunogenicity issues. We highlight the importance of identifying robust biomarkers to predict response and the need to determine patient-specific factors, including the contribution of inflammatory mechanisms to disease activity, to inform treatment strategies and improve long-term outcomes. Promising results with more recently marketed biologic and targeted synthetic DMARDs, and the use of combination treatment approaches, offer new options for managing treatment-experienced patients.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"867-882"},"PeriodicalIF":13.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12185568/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144062858","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}

{"title":"Datopotamab Deruxtecan: First Approval.","authors":"Hannah A Blair","doi":"10.1007/s40265-025-02185-x","DOIUrl":"10.1007/s40265-025-02185-x","url":null,"abstract":"<p><p>Datopotamab deruxtecan (DATROWAY^®) is a trophoblast cell surface antigen 2 (TROP2)-directed antibody-drug conjugate being developed by Daiichi Sankyo and AstraZeneca for the treatment of solid tumours. On 27 December 2024, datopotamab deruxtecan was approved in Japan for the treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative unresectable or recurrent breast cancer after prior chemotherapy. The drug has since been approved on 17 January 2025 in the USA for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. Datopotamab deruxtecan has also been approved in the EU for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. Regulatory review of datopotamab deruxtecan in breast cancer is underway in Canada and China. This article summarizes the milestones in the development of datopotamab deruxtecan leading to this first approval for the treatment of HR positive, HER2 negative breast cancer.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"965-975"},"PeriodicalIF":13.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143969071","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}

{"title":"Vonoprazan: A Review in Erosive Esophagitis and Non-Erosive Gastro-Esophageal Reflux Disease.","authors":"Simon Fung","doi":"10.1007/s40265-025-02193-x","DOIUrl":"10.1007/s40265-025-02193-x","url":null,"abstract":"<p><p>Vonoprazan (Voquezna^®) is a potassium-competitive acid blocker (PCAB) with improved pharmacodynamic and pharmacokinetic properties compared with proton-pump inhibitors (PPIs) that allow for stronger control of gastric acid with once-daily oral administration and no requirement to be taken in relation to timing of meals for optimal efficacy. In the USA, vonoprazan has been approved as a first-in-class treatment for healing and maintenance of healing of erosive esophagitis, and for relief of heartburn in adult patients with erosive esophagitis and non-erosive gastro-esophageal reflux disease (GERD). In pivotal phase III trials, vonoprazan was non-inferior to the PPI lansoprazole in healing and superior to lansoprazole in maintenance of healing of erosive esophagitis, and was superior to placebo for treating heartburn in US patients with non-erosive GERD. Vonoprazan was generally well tolerated; the most common adverse events included abdominal pain, constipation, diarrhea, nausea, and dyspepsia. Vonoprazan is, therefore, a valuable addition to the therapies available for adults with erosive esophagitis and non-erosive GERD.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"945-955"},"PeriodicalIF":13.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093123","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}

{"title":"Treatment of Advanced HIV in the Modern Era.","authors":"Joseph M Garland, Haim Mayan, Rami Kantor","doi":"10.1007/s40265-025-02181-1","DOIUrl":"10.1007/s40265-025-02181-1","url":null,"abstract":"<p><p>Antiretroviral therapy has transformed human immunodeficiency virus (HIV) infection from a fatal illness into a manageable chronic condition. However, despite remarkable progress, the HIV epidemic remains a global health challenge, with ambitious targets such as 95-95-95 by 2030 at risk of being unmet. While antiretroviral therapy availability has expanded worldwide, gaps persist, including unawareness of HIV status, inconsistent medication uptake, and limited engagement in care across diverse settings. Advanced HIV represents a particularly challenging yet underexplored aspect of HIV care. Its definition is complex, complicating efforts to address the needs of this vulnerable population. This review characterizes advanced HIV populations, defines them by spectra of immune suppression, antiretroviral therapy exposure, and drug resistance, and explores contemporary approaches to their management, with a particular focus on drug resistance and its clinical implications in modern HIV care. It highlights the unique challenges faced by individuals presenting late to care, those with limited care engagement, and aging populations with long-term exposure to HIV and antiretroviral therapy. By defining these populations, refining our understanding of advanced HIV, and addressing the diverse needs of affected individuals, providers can enhance outcomes and develop strategies to overcome barriers to care. Bridging these critical gaps is essential to advancing global efforts to end the HIV epidemic, both in the USA and worldwide.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"883-909"},"PeriodicalIF":13.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12277976/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143996167","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}

{"title":"Chronic Obstructive Pulmonary Disease (COPD): Developments in Pharmacological Treatments.","authors":"Dave Singh, Andrew Higham, Alexander G Mathioudakis, Augusta Beech","doi":"10.1007/s40265-025-02188-8","DOIUrl":"10.1007/s40265-025-02188-8","url":null,"abstract":"<p><p>The immediate goals of pharmacological management in chronic obstructive pulmonary disease (COPD) are to minimise symptoms and improve exercise performance. The longer-term goals are to reduce the future risk of exacerbations, lung function decline and mortality. It is now recognised that a subset of COPD patients have type 2 inflammation, which is identified by the presence of higher blood eosinophil counts (BEC). Individuals with higher BEC show a greater response to pharmacological interventions targeting type 2 inflammation, including inhaled corticosteroids and the monoclonal antibody, dupilumab. The use of BEC as a biomarker to guide pharmacological treatment has enabled a precision medicine approach in COPD. This article reviews recent advances in the pharmacological treatment of COPD, encompassing the optimum use of inhaled combination treatments and the evidence to support the use of the novel inhaled phosphodiesterase inhibitor ensifentrine and monoclonal antibodies in patients with COPD.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"911-930"},"PeriodicalIF":13.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12185658/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144109847","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}