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

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...