Monday, May 23, 2011

FDA Approves Vertex's Hep C Cure -- Incivek® -- Let The (Pricing) Battle Begin!

Right on schedule -- the "best in class" Hep C cure (commonly known as Telaprevir, but now branded by Vertex Pharma as Incivek®) has been approved by the full FDA, pre-NASDAQ-market open, this morning:

. . . .The safety and effectiveness of Incivek was evaluated in three phase 3 clinical trials with about 2,250 adult patients who were previously untreated, or who had received prior therapy. In all studies patients also received the drug with standard of care. In previously untreated patients, 79 percent of those receiving Incivek experienced a sustained virologic response (i.e. the infection was no longer detected in the blood 24 weeks after stopping treatment) compared to standard treatment alone.

The sustained virologic response for patients treated with Incivek across all studies, and across all patient groups, was between 20 and 45 percent higher than current standard of care.

The studies indicate that treatment with Incivek can be shortened from 48 weeks to 24 weeks in most patients. Sixty percent of previously untreated patients achieved an early response and received only 24 weeks of treatment (compared to the standard of care of 48 weeks). The sustained virologic response for these patients was 90 percent.

When a person achieves a sustained virologic response after completing treatment, this suggests that the hepatitis C infection has been cured. . . .

So, will Vertex price Incivek above that set be Merck for Victrelis? We'll know in moments.

No comments: