Schizophrenia Treatment Revolution: FDA Approves Bristol Myers Squibb' Cobenfy As New Class Of Treatment In More Than 3 Decades
Schizophrenia Treatment Revolution: FDA Approves Bristol Myers Squibb' Cobenfy As New Class Of Treatment In More Than 3 Decades
"Today's landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community, where after more than 30 years, there is now an entirely new pharmacological approach for schizophrenia — one that has the potential to change the treatment paradigm," said Chris Boerner, board chair and CEO at Bristol Myers Squibb.On Thursday, the FDA approved Bristol Myers Squibb & Co's (NYSE:BMY) Cobenfy (xanomeline and trospium chloride, KarXT), an oral medication for schizophrenia in adults.
上周四，FDA批准了傲石明治（KarXT，karuna therapeutics）口服药物Cobenfy（艾左氨咪明和曲斯匹克氯化铜，用于成年精神分裂症治疗）
Bristol-Myers added the treatment via Karuna Therapeutics deal for $330 per share in cash for a total equity value of $14 billion.
Bristol-Myers以每股330美元的现金增购股份，总市值达140亿美元
Cobenfy represents the first new class of medicine in several decades and introduces a fundamentally new approach to treating schizophrenia by selectively targeting M1 and M4 receptors in the brain without blocking D2 receptors.
Cobenfy代表数十年来首个新药物类别，并通过选择性靶向大脑中的M1和M4受体而引入了治疗精神分裂症的基本全新方法，而不阻塞D2受体
"Today's landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community, where after more than 30 years, there is now an entirely new pharmacological approach for schizophrenia — one that has the potential to change the treatment paradigm," said Chris Boerner, board chair and CEO at Bristol Myers Squibb.
“今天对我们首个精神分裂症一流治疗方案的历史性批准标志着社区的一个重要里程碑，经过30多年后，现在有了一个完全新的精神分裂症药物治疗方案——这有潜力改变治疗范式，”Bristol Myers Squibb的董事长兼首席执行官Chris Boerner表示
Schizophrenia is estimated to impact approximately 2.8 million people in the U.S.
据估计，精神分裂症影响美国约280万人
The FDA approval of Cobenfy is supported by data from the EMERGENT clinical program, which includes three placebo-controlled efficacy and safety trials and two open-label trials evaluating the long-term safety and tolerability of COBENFY for up to one year.
Cobenfy的FDA批准得到了EMERGENt临床项目的数据支持，该项目包括三项安慰剂对照疗效和安全性试验以及两项评估COBENFY长期安全性和耐受性的开放标签试验，长达一年
In Phase 3 EMERGENT-2 and EMERGENT-3 trials, Cobenfy met its primary endpoint, demonstrating statistically significant reductions of schizophrenia symptoms compared to placebo, as measured by the Positive and Negative Syndrome Scale (PANSS) total score change from baseline to week five.
在第3阶段EMERGENt-2和EMERGENt-3试验中，Cobenfy实现了其主要终点，显示与安慰剂相比在第五周的阳性与阴性综合症尺度（PANSS）总得分变化方面有统计学上显著的减少
Cobenfy demonstrated a 9.6-point reduction (-21.2 Cobenfy vs. -11.6 placebo) and an 8.4-point reduction (-20.6 Cobenfy vs. -12.2 placebo) in PANSS total score compared to placebo at week five in EMERGENT-2 and EMERGENT-3, respectively.
Cobenfy在EMERGENt-2和EMERGENt-3的第五周分别与安慰剂相比实现了9.6分（-21.2 Cobenfy vs. -11.6 安慰剂）和8.4分（-20.6 Cobenfy vs. -12.2 安慰剂）的PANSS总得分减少
In EMERGENT-2, Cobenfy demonstrated a statistically significant improvement in illness from baseline to week five.
在EMERGENt-2中，Cobenfy表现出病情在基线到第五周有统计学显著改善。
Cobenfy was invented at PureTech Health Plc (NASDAQ:PRTC). FDA approval triggers two separate milestone payments to PureTech totaling $29 million.
Cobenfy是在puretech health Plc（纳斯达克:PRTC）发明的。FDA批准将触发两笔分别为2900万美元的里程碑付款给puretech health。
Price Action: BMY stock is up 6.34% at $53.30 during the premarket session at last check Friday.
股票价格走势：BMY股价在最后检查时的盘前交易中上涨了6.34%，报53.30美元，时间是上周五。
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图片来自shutterstock。
