FDA Delays Decision on Gilead’s Truvada to Prevent HIV
This article is for subscribers only.
Gilead Sciences Inc., the world’s largest maker of AIDS drugs, said U.S. regulators delayed by three months a decision on whether the company can expand use of its HIV treatment Truvada as a therapy to prevent the virus.
The Food and Drug Administration moved the target date to Sept. 14 so it can review a plan by Gilead to ensure people wouldn’t misuse the drug, the Foster City, California-based company said yesterday in an e-mail. Gilead provided the agency a modified risk strategy on June 4, Cara Miller, a spokeswoman for the company, said in the e-mail.