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Reuters Health Information (2011-05-23): Vertex hepatitis C drug Incivek (telaprevir) wins U.S. approval


Vertex hepatitis C drug Incivek (telaprevir) wins U.S. approval

Last Updated: 2011-05-23 13:33:24 -0400 (Reuters Health)

NEW YORK (Reuters) - Vertex Pharmaceuticals Inc's highly anticipated hepatitis C drug Incivek, also known as telaprevir, won U.S. approval, heralding a new era of treatment for the liver-destroying disease.

The approval, announced by the Food and Drug Administration said on Monday, was widely expected after an FDA advisory panel unanimously recommended the drug last month. The agency approved another hepatitis C drug, Merck & Co Inc's Victrelis, earlier this month.

Incivek, also known as telaprevir, is poised to help transform treatment of hepatitis C by nearly doubling the chances of a sustained virologic response.

In clinical studies, 79% of patients taking Incivek had a sustained virologic response 24 weeks after stopping treatment -- compared to standard treatment with interferon and ribavirin, the FDA said.

Incivek, a pill, is expected to control more of the market because it has shown a higher cure rate than Merck's Victrelis.

Doctors say tens of thousands of hepatitis C patients have been delaying treatment in anticipation of the new medicines, which must be taken in combination with older hepatitis drugs. About 170 million people around the world are infected with hepatitis C.

Vertex said Incivek will arrive in pharmacies this week.

"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, director of the FDA drug center's office of antimicrobial products.

The most commonly reported side effects with Incivek include rash, anemia, nausea, fatigue, headache, diarrhea, itching and anal or rectal irritation and pain, the FDA said.

The agency said the rash can be serious and can require stopping Incivek or all three drugs in the treatment regimen.

Brian Skorney, an analyst at Brean Murray, Carret & Co, said he expects Incivek and Victrelis to initially split the market fairly evenly, with Incivek gradually gaining a bigger share over the next six months to a year.

Last week Merck struck a deal with Roche Holding AG under which Roche will co-promote Victrelis in the United States. Roche and Merck dominate the market for interferons, which must be given with the new drugs.

"There's certainly some pricing strategies around interferons that Merck and Roche may be able to use," Skorney said.

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