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FDA Panel Endorses Vertex Hepatitis C Drug

An expert advisory panel has unanimously recommended a hepatitis C drug from Cambridge-based Vertex Pharmaceuticals Inc.

On Thursday, the panel of medical experts discussed the drug trials and other research on telaprevir, a therapy for hepatitis C developed by the Cambridge drug company. Calling it a stunning breakthrough drug, the panel says the U.S. Food and Drug Administration should approve it.

"We’re very confident in the data and we’re also thrilled by the decision," said Vertex Vice President for Medical Affairs Shelley George. "So we’re just waiting, you know, for the next step, for the approval."

The unanimous vote makes it highly likely that the FDA will say "yes" to the drug soon, as the agency generally follows the recommendations of its panels. A final decision is expected by May 23.

It would be the first major commercial product from Vertex, and telaprevir is a potential blockbuster in a multibillion dollar market.

But on Wednesday the same panel also unanimously recommended approval for Merck's drug boceprevir, a similar drug for hepatitis C. So, telaprevir would have stiff competition.

Both Merck and Vertex have spent more than 15 years developing more effective therapies for the virus that infects about 3.2 million people in the U.S., or about 1.5 percent of the population.

"Vertex has been working on this project since 1993," George said. "So it's an important milestone that we've achieved, for both the company and for patients out there."

The Associated Press contributed reporting.

Earlier:

This program aired on April 28, 2011. The audio for this program is not available.

Curt Nickisch Twitter Business & Technology Reporter
Curt Nickisch was formerly WBUR's business and technology reporter.

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