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Incivek Black Box Creates Fallout Risk For Vertex, FDA On Rash-related Fatalities

For Vertex, the key question is how much is physician and patient concern about the adverse events is already reflected in the softening sales of the hepatitis C drug; for FDA, the question is how effective will label-based risk management be.

Vertex Pharmaceuticals Inc.’s Incivek (telaprevir) obtained FDA approval as an advancement in the treatment of chronic hepatitis C despite the frequent occurrence of rash, sometimes serious, in patients receiving the drug during clinical trials. Now, more than 18 months after launch, FDA is adding a black box warning to the Incivek label due to reports of severe rash-related adverse events, some of which resulted in death.

FDA and the Cambridge, Mass.-based biotech announced the label revision Dec. 19, with the agency stipulating that HCV patients receiving...

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