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 이성욱 ( 2010-11-25 12:47:13 , Hit : 3435
 Vertex submits application for hepatitis C drug


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Sending your articleYour article has been sent. Globe Staff

Vertex Pharmaceuticals Inc. said today that it has completed the submission of a New Drug Application that seeks regulatory approval for telaprevir, a hepatitis C drug candidate with the potential to generate billions of dollars in annual revenue.

The submission includes a request to the US Food and Drug Administration to reduce the FDA’s review time from 10 months to six months, Cambridge-based Vertex said in a press release.

The release included a statement Matthew Emmens, the company's chairman, president, and chief executive.

“This submission is a milestone in our more than 15-year effort to change the way hepatitis C is treated,” Emmens said. “We are committed to working closely with the FDA to make telaprevir available as quickly as possible to the millions of people with hepatitis C who need new medicines to increase their chances for a viral cure.”

A recent Globe story noted that Vertex was on the verge of moving forward on telaprevir. One challenge: Global drug giant Merck & Co. is developing its own hepatits C drug candidate that could compete with telaprevir for the same market.









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