Merck ($MRK) has stolen a small lead in its hot race with Vertex ($VRTX) for regulatory approval of a new hepatitis C treatment. The pharma giant says that regulators in the U.S. as well as Europe have accepted its applications for boceprevir. And the FDA plans on an expedited, six month review.
Vertex, meanwhile, is still waiting for confirmation from the FDA on its closely-watched application for telaprevir, which it confidently expects will win approval this year after presenting a mountain of promising late-stage data on its behalf. Word should arrive in the next couple of weeks, though, which will help the market handicappers estimate where these two drug prospects are likely to land later in 2011.
"We are pleased that the FDA and EMA have accepted boceprevir for expedited review. Our goal is to be able to bring forward a new treatment option for patients living with chronic hepatitis C, and we are now closer to that goal," said Dr. Peter Kim, president, Merck Research Laboratories.
There's no such thing as a sure thing in drug development, but both drugs are considered odds-on favorites for an approval. And they promise to shake up the hep C treatment field in short order.
- here's the Merck release