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FDA Approves New Hepatitis C Drug

May 23, 2011

Vertex Pharmaceuticals Inc.’s highly anticipated hepatitis C drug has finally won U.S. approval, which will usher in a new marketing battle with a rival medicine from Merck & Co.

Incivek is poised to help transform treatment of hepatitis C by nearly doubling the chances of curing the serious liver disease.  Some industry analysts project Incivek sales will top $5 billion a year.

The approval was widely expected after an FDA advisory panel unanimously recommended the drug last month.

About 79 percent of patients in the clinical study taking Incivek experienced a sustained virology response.  Older drugs cure only about 40 percent of patients.

Doctors say tens of thousands of hepatitis C patients have been delaying treatment in anticipation of the new medicines.  About 170 million people around the world are infected with hepatitis C.

Vertex said Incivek will arrive in pharmacies this week.

The drug is expected to eventually control more of the market because it has shown a higher cure rate than Victrelis, which had a 66 percent cure rate in late-stage studies.

“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,” Edward Cox, director of the FDA drug center’s office of antimicrobial products, said in a statement.

The FDA said the most commonly reported side effects with Incivek include rash and anemia.

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

Victrelis is made up of pegylated interferon and ribavirin for genotype 1 chronic hepatitis C and was approved by U.S. regulators in 1998.

“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, director of the office of antimicrobial products in 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.”

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