Bloomberg News

Gilead’s Hepatitis C Drug to Get Priority Review by U.S. FDA

June 07, 2013

Gilead Sciences Inc. (GILD:US), the world’s largest maker of HIV medicines, said its experimental hepatitis C pill, sofosbuvir, will receive a priority marketing review by U.S. regulators.

Gilead applied to gain approval of the drug in combination with ribavirin, a current treatment, as an oral therapy for patients with two types of the virus and with ribavirin and interferon for patients with other types of the infection who have never received treatment. The Food and Drug Administration has set a target review date of Dec. 8, Foster City, California-based Gilead said today in a statement.

Gilead is competing with drugmakers including Bristol-Myers Squibb Co. (BMY:US) and AbbVie Inc. (ABBV:US) to gain approval for oral hepatitis C treatments that don’t involve injections of interferon, which can cause flu-like symptoms. Hepatitis C attacks the liver and can lead to liver cancer. The virus affects about 150 million people worldwide and the market for new pills is estimated at $20 billion.

A priority review, granted to drugs that may provide major advances in treatment, speeds FDA evaluation to eight months, rather than usual 12.

Gilead gained 3 percent to $52.89 at the close in New York before the announcement. The stock has more than doubled (GILD:US) in the past 12 months.

To contact the reporter on this story: Andrew Pollack in San Francisco at apollack1@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net


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Companies Mentioned

  • GILD
    (Gilead Sciences Inc)
    • $88.98 USD
    • 0.04
    • 0.04%
  • BMY
    (Bristol-Myers Squibb Co)
    • $48.5 USD
    • -0.01
    • -0.02%
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