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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.