Vertex Seeks FDA Green Light for Hepatitis C Drug; Chomps at the Bit For Fast Review

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committed to working closely with the FDA to make telaprevir available as quickly as possible to the millions of people with hepatitis C who need new medicines to increase their chances for a viral cure.”

Hepatitis C is currently treated with pegylated interferon alpha and ribavirin, a combination therapy that causes flu-like symptoms, and which many patients consider worse than the disease itself, which can lie dormant for years. Telaprevir, an oral pill taken three times a day, is designed to attack the virus through a different mechanism than the other meds, as a member of the class of protease inhibitors. Vertex’s success at boosting viral cure rates and reducing the dependence on a widely loathed standard regimen has invited one serious late-stage competitor—Merck’s boceprevir. It has also helped inspire a wide array of other companies to attack the virus in various cocktail regimens with nucleoside inhibitors and non-nucleoside inhibitors, through a strategy that resembles the multi-drug approaches that are now standard therapy for HIV.

There are a lot of details about the safety and effectiveness of this drug in its main clinical trials, which I won’t attempt to repeat here. You can follow the links to our past coverage, including a Phase III results preview story in May, followed by the reports on the critical trials known as Advance, Illuminate, and Realize. You can also get a sense of Vertex’s vision for commercializing this drug through a profile of Emmens that ran back in January.

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2 responses to “Vertex Seeks FDA Green Light for Hepatitis C Drug; Chomps at the Bit For Fast Review”

  1. I have 1st stages of scirosis of liver will i be able to take telepravir?, for my gi dr. says i cannot take current treatment{ combo drugs} for it would be lifethreatening.