A Food and Drug Administration panel unanimously backed the approval of Vertex Pharmaceuticals Inc.'s (VRTX) proposed hepatitis C-drug telaprevir, saying it showed strong effectiveness, a day after also endorsing a similar product from Merck & Co. (MRK).
The panel of non-FDA medical experts voted 18-to-0 on a question that asked whether the available data support approval of the telaprevir in combination with other hepatitis C drugs, pegylated interferon and ribavirin. The vote amounts to a recommendation that the agency approve telaprevir. The FDA usually follows the advice of its advisory panels but isn't required to.
Wall Street analysts widely expect the FDA to approve telaprevir and Merck's boceprevir as both have demonstrated significant effectiveness in improving the cure rates in patients who use standard therapy for hepatitis C. One panel member called telaprevir "stunning advance" in the treatment of hepatitis C.
Both drugs are known as protease inhibitors and are designed to block an enzyme that helps the hepatitis C virus replicate. Vertex owns the North American rights to the telaprevir and would get a royalty on overseas sales from partner Johnson & Johnson (JNJ).
"We are excited by today's unanimous vote to recommend FDA approval of telaprevir, as people with hepatitis C urgently need more effective medicines," said Camilla Graham, the vice president of global medical affairs at Vertex.
Hepatitis C is a liver disease caused by infection with the hepatitis C virus, which is transmitted through contaminated blood. The infection can cause liver failure, liver cancer and is the leading cause of liver transplants, FDA said. About 3.2 million Americans are infected with hepatitis C.
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