FDA approves mega-blockbuster Vertex hep C drug Incivek

Tools

Right on its PDUFA deadline the FDA announced that it has approved Vertex's blockbuster hepatitis C treatment Incivek, better known in the trade as telaprevir. And regulators were quick to bill the approval as a package deal, with Merck's newly approved boceprevir helping to significantly advance the standard of care for millions of patients.

"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, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "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 hepatitis C infection."

For Vertex, the approval marks the proverbial game-changer, vaulting the company from a promising biotech with a compelling pipeline to a full-fledged biopharma operation with the responsibility for marketing the mega-blockbuster in the U.S. Analysts have estimated peak sales at up to $5 billion. And the biotech company is now ready to field a sales force of 115 reps who will market the drug at a cost of $49,200 for a 12-week course of treatment.

The approval also marks another plus for J&J, which holds European rights to the treatment and will likely gain an OK there as well in the near future. Now Vertex will square off against Merck and its new marketing partner Roche, which have ambitious plans of their own for marketing boceprevir.

For patients the approval marks a whole new standard of care, with a new treatment that promises to eradicate signs of hep C quickly. And for many it could prove to be the first hep C treatment that their body will be able to stand.

Significantly, the approval comes with no strings attached regarding REMS or a black box warning.

"Today marks a turning point in the fight against hepatitis C, particularly for people who have been living with this silent disease for decades, hoping for a better chance of a viral cure," said Matthew Emmens, the CEO of Vertex. "The approval of Incivek was only possible thanks to more than 4,000 people who volunteered for our clinical studies, the doctors, nurses and coordinators who managed the studies, and our own pioneering scientists who have worked for more than 15 years to bring this new medicine to people with hepatitis C."

- see the release from the FDA
- here's Vertex's release
- here's the Reuters story
- take a look at the label

Related Articles:
Hold your breath for Vertex's big telaprevir moment
FDA panel unanimously backs Vertex's Hep C drug telaprevir
Vertex offers a blockbuster case for telaprevir
FDA team applauds telaprevir's efficacy, raises safety concerns