HIV Drug Truvada Delayed From FDA Approval

The HIV drug Truvada, made by Gilead Sciences (GILD) will wait another three months before U.S. regulators decide to approve its use, citing the need to review the company’s risk mitigation plan.

Mercury News reports that an advisory panel recommended that the Food and Drug Administration approve Truvada as a treatment for preventing the HIV infection among people who are at risk for contracting AIDS, which includes homosexual and bisexual men.

If the Gilead drug is approved, it will become the first of its kind marketed for prevention of the deadly disease. The decision was originally expected by June 15th, but company spokeswoman Cara Miller stated that the new deadline is set for September 14th.

The drug will also be marketed toward partners of those infected with HIV. The decision to delay approval comes after a May meeting in which a committee of FDA advisors recommended that the agency approve Truvada for use in specific high-risk groups. Following the meeting though, the FDA asked Gilead to revise the risk-management plan for the drug.

According to The Washington Post, the biggest safety worry for the FDA and Gilead is that people who are already diagnosed with HIV will take the drug, which could lead to a drug-resistant, difficult-to-treat HIV strain. To combat this, Mitchell Warren, executive director of AVAC, an AIDS advocacy group, believes that a HIV testing plan that ensures those taking Truvada are negative for the virus, is “pivotal.” He stated:

“Gilead has said they will provide free HIV testing [to potential Truvada takers]. That’s terrific. Hopefully the back-and-forth between Gilead and FDA will provide more clarity on how they’ll do that.”