Madrigal Pharmaceuticals has hired Carole Huntsman as its new chief commercial officer to help the biotech navigate a new and potentially tricky launch in nonalcoholic steatohepatitis (NASH).

Madrigal Pharmaceuticals聘请Carole Huntsman作为其新的首席商务官，帮助生物技术在非酒精性脂肪性肝炎（NASH）中开创一个新的且可能棘手的推出。

This comes after Madrigal started a rolling submission with the FDA for resmetirom in NASH, a form of fatty liver disease, back in the summer.

这是在Madrigal于夏天开始向FDA提交纳什resmetirom（一种脂肪肝疾病）的滚动提交之后。

It has since revealed more positive data demonstrating the experimental drug's efficacy in reducing fat in the liver. An FDA decision on the drug is anticipated by March 14. If all goes well (though in NASH, that is far from certain), a launch could occur later in the year, marking the first approval for a drug targeting this condition..

它揭示了更多积极的数据，证明了实验药物在减少肝脏脂肪方面的功效。预计3月14日FDA将对该药物作出决定。如果一切顺利（尽管在纳什，这还不确定），发射可能会在今年晚些时候发生，标志着针对这种情况的药物的首次批准。。

Madrigal, hoping the FDA will give it the green light for a launch, has hired Huntsman to help shore up the company and transform it from an R&D biotech into a commercial outfit and help push the drug’s trajectory as high as possible. She has some strong credentials, having most recently served as senior vice president and head of specialty care for North America and U.S.

Madrigal希望FDA能够为它发射绿灯，他聘请了Huntsman来帮助支持该公司，并将其从研发生物技术转变为商业装备，并尽可能地帮助推动该药物的发展轨迹。她拥有一定的证书，最近曾担任北美和美国的高级副总裁和专业护理负责人。

country lead at Sanofi..

赛诺菲国家牵头。。

There, she helped launch Dupixent, the immunology drug co-marketed by Sanofi and Regeneron, into what has become a megablockbuster franchise.

在那里，她帮助推出了由赛诺菲和Regeneron共同销售的免疫药物Dupixent，成为一家巨型炸弹特许经营企业。

Huntsman comes on board with another former Sanofi alum in the guise of Madrigal’s new CEO Bill Sibold, who also worked at the French Big Pharma, most recently as its executive vice president of specialty care and president of North American operations.

亨茨曼以马德里加尔新首席执行官比尔·西博尔德（Bill Sibold）的名义与另一位前赛诺菲明矾公司合作，他也曾在法国大制药公司工作，最近担任专业护理执行副总裁和北美运营总裁。

He took over in September, leading to a wobble in the company’s stock price as investors questioned the company’s decision to change leaders so close to its potential launch date.

他于9月接管，导致公司股票价格下跌，因为投资者质疑公司决定更换如此接近其潜在推出日期的领导者。

Selling the drug for NASH may pose a greater challenge for the Sanofi veterans. This condition, affecting tens of millions of Americans, is commonly associated with obesity and can, in some instances, lead to liver damage, increasing the risk of liver failure and death.

销售NASH药物可能对赛诺菲退伍军人构成更大的挑战。这种影响数千万美国人的疾病通常与肥胖有关，并且在某些情况下可能导致肝损伤，增加肝功能衰竭和死亡的风险。

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UPDATED: Intercept restructures as Ocaliva's NASH hopes dashed again with FDA rejection

更新：拦截重组，因为Ocaliva的NASH希望再次因FDA拒绝而虚线

Numerous attempts have been made to bring a NASH drug to the FDA finish line, but the path to approval is fraught with failures. Most recently, and devastatingly for the company, Intercept Pharmaceuticals faced a setback in this pursuit.

已经做了许多尝试将NASH药物带到FDA的终点线，但是批准的途径充满了失败。最近，对于该公司而言，具有破坏性的是，Intercept Pharmaceuticals在这一追求中面临挫折。

Intercept first nabbed an approval for its drug Ocaliva in 2016 for primary biliary cholangitis but has for years tried to get a second label in the more lucrative NASH space. The long journey to an FDA approval for the company ended this year after a second FDA rejection that led Intercept to ditch its NASH hopes and restructure..

Intercept首先在2016年获得了原发性胆汁性胆管炎药物Ocaliva的批准，但多年来一直试图在更有利可图的NASH领域获得第二个标签。FDA批准该公司的漫长旅程今年结束，原因是FDA第二次拒绝，导致拦截放弃了NASH希望并重组。。

This regulatory failure followed from a whole series of trial flops and setbacks in NASH over the past five years, including for Genfit, Novo Nordisk, Akero Therapeutics, Conatus/Novartis and many others, which all failed to make their therapies work well enough and safe enough in trials to warrant an approval..

在过去五年中，包括Genfit，Novo Nordisk，Akero Therapeutics，Conatus/Novartis和许多其他公司在内的一系列试验失败和NASH挫折之后，这种监管失败都未能使其治疗效果良好，在试验中足够安全，值得批准。。

A successful NASH drug could still prove to be a megablockbuster for any company if it can produce the right results and a strong launch.

如果一种成功的NASH药物能够产生正确的结果并大幅推出，那么它仍然可以被证明是任何公司的巨型炸弹。

Analysts have agreed that Madrigal’s once-daily oral thyroid hormone receptor is likely to be the first NASH treatment to make it to market, and Mizuho analysts have previously forecast that the biotech could see $1 billion in peak sales as the first in the indication.

分析师一致认为，Madrigal每日一次的口服甲状腺激素受体可能是第一个将其推向市场的NASH治疗方法，Mizuho分析师此前曾预测，该生物技术可能会出现10亿美元的峰值销售额。

But being first to market also has its drawbacks: Madrigal will need to beat the first path and convince patients and healthcare professionals about the need for this new drug as well as educate on diagnosis. This is where Huntsman’s experience will come into play.

但首先上市也有其缺点：Madrigal需要击败第一条道路，说服患者和医疗保健专业人员需要这种新药以及进行诊断教育。这就是亨茨曼的经验将发挥作用的地方。

“Carole Huntsman’s leadership skills and experience are a perfect fit for Madrigal as we prepare for a first-to-market launch of resmetirom in the U.S.,” said Sibold in a press release.

“Carole Huntsman的领导技能和经验非常适合Madrigal，因为我们准备在美国首次上市推出resmetirom，”Sibold在新闻稿中说。

“She has an extensive track record of specialty launch success and excels in building and leading high-performing teams that deliver innovative new therapies to patients with serious diseases. I’m thrilled to welcome Carole to Madrigal and look forward to working with her as we continue to build a world-class commercial organization.”.

“她在专业发射成功方面有着广泛的记录，在建立和领导高绩效团队方面表现出色，为严重疾病患者提供创新的新疗法。我很高兴欢迎Carole来到Madrigal，并期待在我们继续与她合作建立一个世界级的商业组织“。