Vertex Files for Hep C Drug Approval
CAMBRIDGE, Mass. (
) --
Vertex Pharmaceuticals
(VRTX) - Get Report
submitted an application to U.S. regulators seeking speedy approval of its experimental hepatitis C drug telaprevir, the company said Tuesday.
The timing of the telaprevir approval filing to the U.S. Food and Drug Administration was widely expected. Vertex asked FDA for priority review, which if granted, would mean an approval decision could be made by June 2011.
"This submission is a milestone in our more than 15-year effort to change the way hepatitis C is treated," said Vertex CEO Matthew Emmens, in a statement.
Merck
(MRK) - Get Report
, Vertex's closest competitor, has not yet announced a U.S. approval filing for its rival Hep C drug boceprevir. Vertex and partner
Johnson & Johnson
(JNJ) - Get Report
said nothing Tuesday about telaprevir's approval filing in Europe but J&J is expected to complete the European filing before the end of the year.
Telaprevir, if approved, will shorten treatment and improve cure rates for patients infected with the Hep C virus. For Hep C patients new to treatment, telaprevir combined with the current standard treatment of long-acting interferon and ribavirin achieved cure rates of 75% in a phase III study, compared to about 40% of patients treated with the standard treatment alone.
More than half of these patients were able to achieve a cure in six months, or about half the time of currently used treatment regimens.
In the other major phase III study enrolling Hep C patients who failed to respond to prior treatment, telaprevir also induced significantly higher cure rates compared to standard therapy.
Vertex shares closed Monday at $34.29.
--Written by Adam Feuerstein in Boston.
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