DOW JONES NEWSWIRES
The U.S. Food and Drug Administration granted Gilead Sciences
Inc.'s (GILD) antiretroviral drug Truvada a priority-review
schedule, advancing what could become the first treatment labeled
for HIV prevention.
By approving Gilead's supplemental new-drug application, the
agency gave Truvada a six-month priority-review schedule, a
designation given to drug candidates that provide major advances or
offer treatment where no adequate therapy exists.
Gilead has dominated the HIV-treatment market. The FDA in August
approved Complera, another Gilead HIV treatment for patients new to
therapy.
The FDA approved Truvada in 2004 as a treatment for HIV-1
infection, making it the most-prescribed antiretroviral treatment
in the U.S. It is not indicated for treatment of uninfected
adults.
Gilead submitted its supplemental application in December. The
agency later set a June 15 target review date for Truvada, and an
advisory panel will discuss the treatment during its regularly
scheduled meeting in May.
The company based its application on results from two large
placebo-controlled trials of Truvada sponsored by the U.S. National
Institutes of Health and the University of Washington.
Shares were recently up 12 cents at $55.02 after hours. The
stock has climbed 43% over the past year.
-By Drew FitzGerald, Dow Jones Newswires; 212-416-2909;
Andrew.FitzGerald@dowjones.com