再生元和赛诺菲的Dupixent对患有特应性皮炎的青少年显示出治疗益处
2020-04-07 11:22:11
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Regeneron Pharmaceuticals(NASDAQ:REGN)和开发合作伙伴Sanofi(NYSE:SNY)宣布了一项3期临床试验的详细结果,该试验评估了Dupixent(dupilumab)在中度至重度特应性皮炎(AD)的青少年(12至17岁)中的应用。数据在巴黎EADV大会上发表。是达到EASI-75的患者比例(症状改善75%),而美国的主要终点指标是达到IGA 0(透明皮肤)或1(几乎透明)的患者的比例。41.5%接受Dupixent的患者每两个周,并且每四周接受一次药物的患者中有38%达到了EASI-75,而安慰剂则为8%(p<0.001).24% of patients receiving weight-based dosing of Dupixent every two weeks and 18% of those receiving a fixed-dose regimen every four weeks achieved IGA 0 or 1 compared to 2% for placebo (p<0.001).Key secondary endpoints were also met.On the safety front, adverse events (AEs) were observed in 72% of patients in two-week group, 64% in the four-week group and 69% for control. The most frequent AEs were injection site reactions (8.5%, 6% and 3.5%, respectively).The results will support global marketing applications.Dupixent was approved in the U.S. in March 2017 and in Europe six months later for adults with moderate-to-severe AD. It is also approved in Japan and Canada.Previously: Regeneron & Sanofi"s Dupixent successful in late-stage dermatitis study in adolescents (May 16)Now read: Your Daily Pharma Scoop: FibroGen Fast Tracked, Dr. Reddy"s Entry, Bristol-Myers SucceedsOriginal article>iv>
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