VX-950 To Get Fast Tracked
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UPDATE 1-Vertex hepatitis C drug will get fast track review
BOSTON, Dec. 8 (Reuters) – Vertex Pharmaceuticals Inc. (VRTX.O: Quote, Profile, Research) said on Thursday that U.S. regulators will review its experimental hepatitis C drug on an accelerated basis.
The Cambridge, Massachusetts-based company said the U.S. Food and Drug Administration granted “fast track” status to the drug, VX-950, a designation given to drugs aimed at treating serious or life-threatening conditions.
The drug is currently in early clinical trials and the company won’t be ready to submit a marketing application until 2008, according to Joshua Boger, its chief executive officer.
Fast track status will, however, speed the drug’s journey to the market as Vertex will have more frequent contact with the FDA, and it will be able to submit data from its clinical trials as it comes in, rather than waiting until the entire package is complete.
Hepatitis C is a liver disease caused by a virus in the blood. It affects about 3.4 million people in the United States.
Vertex’s drug is an oral treatment that goes into the blood stream and blocks the HCV protease, a protein the hepatitis C virus makes in the liver cells. Blocking the protein prevents the virus from reproducing.
The company hopes that the drug will dramatically shorten the time it takes to eliminate the virus from the blood stream. Current treatments typically take a year to reduce the virus to undetectable levels and only work in about 50 percent of patients.
The current standard of care is a combination of pegylated interferon and ribavirin. Vertex plans to test its drug in combination with pegylated interferon next year.
