The FDA, as promised, rendered its verdict today on Vertex's Incivek (telaprevir) by approving it for the treeatment of hepatitis C for new untreated patients and for those who have not responded well to treatment with interferon and ribavarin.
The approval was widely expected as Incivek had shown in clinical trials an ability to cure almost 80 percent of those treated and in half the time (24 weeks versus the standard 48 weeks). The sustained virologic response was between 20 and 45 percent above the current standard of care.
It's these type of results that have analysts predicting that Incivek may hit sales totals of $2.5 billion annually within a couple of years. The drug is expected to bring more of the estimated 3.2 million US hepatitis C patients into treatment programs.
"With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition," said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA's CDER.
Now it is up to Vertex and its rival team of Merck/Roche to educate the market on the new treatment options versus the interferon/ribavarin standard of care and to start converting patients to the new possibilities for a cure. Of course, there will also be a battle for share and dollars as well. See Fierce Biotech and Xconomy.
Posted by Bruce Lehr May 23rd 2011.