Gilead's hepatitis C drug safe, effective -U.S. FDA reviewers

Reuters

By Toni Clarke

Oct 23 (Reuters) - Gilead Sciences Inc's sofosbuvirdrug is safe and effective when used in combination with othertherapies to treat hepatitis C, according to reviewers with theU.S. Food and Drug Administration.

Their review was posted on the FDA website on Wednesdayahead of an Oct. 25 meeting of an outside panel of medicalexperts who will recommend whether or not the agency shouldapprove the drug.

"The currently available data support a favorablebenefit-risk assessment for the use of sofosbuvir as part of acombination regimen for the treatment of chronic hepatitis C,"the reviewers said. "No major safety issues associated withsofosbuvir use have been identified to date."

Gilead is seeking approval to market the drug in combinationwith an existing treatment, ribavirin, for patients with twovariants of the liver-damaging disease: genotype 2 and genotype3, and for patients awaiting a liver transplant.

If approved, this would be the first all-oral treatment forgenotypes 2 and 3. Current therapies typically includeribavirin, a pill, and the once-weekly injectable druginterferon. Both can cause debilitating side effects.

Gilead is also seeking to market sofosbuvir in combinationwith ribavirin and interferon for patients with genotype 1,regardless of prior treatments, and for patients with genotypes4, 5 and 6 who have not previously been treated.

Bristol-Myers Squibb Co and Abbvie Inc haveadvanced all-oral clinical trial programs in late-stagedevelopment, using a variety of so-called direct actingantivirals, which directly interfere with the virus's ability toreplicate, but Gilead is widely seen to be in the lead.

Chronic hepatitis C affects at least 3 million people in theUnited States, according to the U.S. Centers for DiseaseControl. Genotype 1 is the most common form, accounting forabout 70 percent of cases.

Analysts on average expect Gilead's drug to generate salesof $1.73 billion in 2014, according to Thomson Reuters data.

Current standard treatments for genotype 1 often include aprotease inhibitor. These are oral drugs that include Merck & CoInc's Victrelis and Vertex Inc's Incivek.

Gilead acquired sofosbuvir, known as a nucleotide analogueinhibitor, with its $11 billion purchase of Pharmasset Inc in2012.

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