根据赛诺菲全球研发主管Dietmar Berger所说,当Dupixent证明能够减少2型炎症后,研发人员采取了“大胆的方法”,即直接进入COPD的III期试验。 对于奔赴成功的彼岸,赛诺菲已经迫不及待。联合再生元,赛诺菲启动了第二项COPD III期试验,预计结果将于2024年读出。如果能获得积极结果,那么几乎可以说,Dupixent拿下COPD适应症举目在...
根据赛诺菲全球研发主管Dietmar Berger所说,当Dupixent证明能够减少2型炎症后,研发人员采取了“大胆的方法”,即直接进入COPD的III期试验。 对于奔赴成功的彼岸,赛诺菲已经迫不及待。联合再生元,赛诺菲启动了第二项COPD III期试验,预计结果将于2024年读出。如果能获得积极结果,那么几乎可以说,Dupixent拿下COPD适应症举目在...
This latest EC approval is based on positive results from two late-stage studies, BOREAS and NOTUS, which evaluated the efficacy and safety of Dupixent in adults who were current or former smokers with moderate-to-severe COPD with evidence of type 2 inflammation. Results showed that Dupixent si...
Published on:September 27, 2024 Tim Smith This approval by the FDA follows positive findings from the pivotal BOREAS and NOTUS trials on adults with uncontrolled COPD. Advertisement Advertisement
Regeneron and SanofiwonFDA approval for Dupixent in COPD in late September 2024. The approval of the antibody in a seventh indication marked the first time the regulator had authorized a biologic in COPD. The FDA approved Dupixent on the strength of clinical data showing the drug reduces exacerba...
作为赛诺菲和再生元的主要增长驱动力,Dupixent是已获得三项批准的畅销药,两家制药商的策略是通过多个临床适应症实现持续增长。2020年6月,这两个合作伙伴概述了Dupixent的下一步临床开发计划,包括用于EoE、慢性阻塞性肺疾病(COPD)、结节性痒疹、慢性自发性...
dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis, chronic spontaneous urticaria (CSU) and chronic obstructive pulmonary disease (COPD) in different age populations. More than 1,000,000 patients are being treated w...
作为赛诺菲和再生元的主要增长驱动力,Dupixent是已获得三项批准的畅销药,两家制药商的策略是通过多个临床适应症实现持续增长。2020年6月,这两个合作伙伴概述了Dupixent的下一步临床开发计划,包括用于EoE、慢性阻塞性肺疾病(COPD)、结节性痒疹、慢性自发性荨麻疹和大疱性类天疱疮的临床试验。
“在审查了赛诺菲/再生元两项具有里程碑意义的 3 期研究(BOREAS 和 NOTUS)发布的数据后,与安慰剂相比,Dupixent(dupilumab)能够在 BOREAS 试验中显著减少 30% 的中度或重度急性 COPD 发作,在 52 周的 NOTUS 试验中减少 34%,并且在 12 周时改善肺功能,并持续 52 周。此外,在圣地亚哥举行的 2024 年美国胸科...
Dupixent is used to treat eczema, eosinophilic or oral-corticosteroid-dependent asthma, chronic rhinosinusitis with nasal polyps, COPD with an eosinophilic phenotype, eosinophilic esophagitis (EOE), chronic spontaneous urticaria, or prurigo nodularis. Du