Telaprevir regulatory update

FDA's Antiviral Drugs Advisory Committee voted 18-0 to recommend approval of telaprevir from Vertex to treat HCV infection. The panel members were impressed by the efficacy of telaprevir. In the Phase III program, telaprevir plus standard of care - pegylated interferon and ribavirin - had rates of sustained virologic response of 65-79% compared with 17-46% for standard care alone. The panel was concerned by the increased rates of rash in the Phase III program, but felt the rash management program proposed by Vertex was sufficient to address the issue. FDA is not asking for a REMS for telaprevir.

Vertex has proposed a treatment regimen of response guided therapy (RGT) in which therapy could be shortened to 24 weeks from 48 weeks in treatment naive and relapsed groups depending on how quickly the patient achieves undetectable levels of HCV RNA. The majority of panel members agreed RGT was appropriate in treatment naïve patients. However, they were mixed about the use of RGT in relapsed patients, as well as black patients. The panel did agree RGT was not appropriate for cirrhotic patients regardless of relapse status. ...