Less than a fortnight after giving the green light to Merck & Co's Victrelis, the US Food and Drug Administration has approved another hepatitis C treatment, Vertex Pharmaceutical's Incivek.
The agency has backed Incivek (telaprevir) for use with interferon therapy made up of peginterferon alfa and ribavirin. The latter combo is the current standard of care for chronic HCV, which is taken for 48 weeks, but less than 50% of patients respond to this therapy.
The FDA approval was expected given that the agency's Antiviral Drugs Advisory Committee voted 18-0 to recommend Incivek at the end of last month. The drug was evaluated in three Phase III trials with about 2,250 patients and among people who were not treated previously, 79% of those receiving Incivek experienced a viral cure 24 weeks after stopping treatment compared to standard treatment alone.
The studies also indicate that treatment with Incivek, a pill taken three times a day with food, can be shortened from 48 weeks to 24 weeks in most patients, as 60% of previously untreated patients achieved an early response. The sustained virologic response for these patients was 90%.
Edward Cox, director of the Office of Antimicrobial Products at the FDA’s Center for Drug Evaluation and Research, said that “with the approval of Incivek, there are now two important new treatment options for HCV that offer a greater chance at a cure for some patients with this serious condition”. He added that “the availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic HCV infection.”_
On May 13, the FDA approved Merck's HCV drug Victrelis (boceprevir) and the race is now on for market share. Vertex says it has a 115-person sales team ready to support the introduction of Incivek, while last week Merck linked up with Roche to co-promote Victrelis.