FDA Must Decide How To Handle Subgroups In Labeling For Boceprevir, Telaprevir
In what is poised to be one of the biggest marketing battles of the year, as Merck's Victrelis (boceprevir) and Vertex's Incivek (telaprevir) close in upon approval, how FDA handles different subgroups of hepatitis C patients in labeling for each of the protease inhibitors could be a determining factor.
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FDA advisory committee briefing documents recommend patients be screened for the Q80K polymorphism because of lower efficacy in those patients, an issue not seen with Incivek or Victrelis.
Much of the hep C wish list was on display at the American Association for the Study of Liver Disease meeting in Boston Nov. 10-13 – all-oral interferon-free drug combinations for hepatitis C, regimens that don’t require ribavirin, and the possibility of a one-pill, once-a-day cure – demonstrating the Gold Rush mentality in the hep C space as drug makers race to put the pieces together and grab a share of a burgeoning market.
Merck will begin shipping Victrelis (boceprevir) to pharmacies within a week, the company announced following FDA approval of the hepatitis C drug after market-close on May 13 – a time-frame that roughly coincides with expected FDA action on Vertex's Incivek (telaprevir).