Alemtuzumab

By , 2013年12月30日 7:42 PM

多発性硬化症治療薬の Alemtuzumabについて、何度かお伝えしてきました (ブログ記事1, ブログ記事2) が、どうやら今回米国では承認されなかったようです。そして、FDAはさらに別の試験デザインで臨床試験を行うことを要求したようです。どうなっていくのでしょうか・・・。

Sanofi says U.S. regulators reject MS treatment Lemtrada

PARIS Mon Dec 30, 2013 2:21pm IST

(Reuters) – Sanofi SA’s Lemtrada multiple sclerosis treatment has failed to win approval from regulators in the United States, dealing a setback to a drug which was at the heart of the French drugmaker’s $20 billion takeover of U.S. biotech firm Genzyme.

The U.S. Food & Drug Administration (FDA) rejected Lemtrada for launch in the world’s biggest drug market on the grounds that Genzyme had not shown its benefits outweighed its “serious adverse effects”, Sanofi said on Monday.

The FDA also demanded Sanofi carry out further clinical trials using different designs and methods prior to approval, Sanofi said. The company responded by saying it strongly disagreed with the decision and planned to appeal. (以下略)


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