Regulatory Focus™ > News Articles > FDA Extends Review of Gilead Sciences' Controversial HIV PrEP Drug Truvada

FDA Extends Review of Gilead Sciences' Controversial HIV PrEP Drug Truvada

Posted 11 June 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) will take an additional three months to review Gilead Science's pre-exposure prophylaxis (PrEP) drug Truvada (tenofovir/emtricitabine) to assess newly-submitted plans to reduce the possible misuse of the drug, reports The Associated Press.

Truvada, currently seeking marketing clearance from FDA to reduce the risk of contracting HIV when used in conjunction with other risk reduction methods, was cleared by an FDA Advisory Committee in May 2012.

The panel voted 19-3 in favor of its indication for men who have sex with men when neither partner has HIV. The panel also voted 19-2 with one abstention to approve a similar indication when one partner has HIV and the other partner does not.

Despite the vote of confidence by the advisory committee, the drug has not been without controversy. In a public letter posted in March 2012, AIDS advisory groups The AIDS Healthcare Foundation (AHF) called for FDA Commissioner Margaret Hamburg's resignation for granting Truvada expedited review status. AHF said the drug "failed to meet the agency's own guidelines for approving an expedited review."

"It's clearly time for a change in leadership at FDA when a drug like PrEP, which has failed several clinical trials and could potentially lead to an increase in HIV infections, is being rushed to market," said Michael Weinstein, president of AHF. The group said in a statement it was "extremely pleased" to hear the agency had agreed to extend its review of the drug.

While the delayed review of Truvada could be seen as a validation of AHF's concerns, Gilead said the delay was simply a result of its submission of additional materials to FDA. The company's materials are intended to show how the company plans to prevent the misuse of the drug-something advisory committee members highlighted as a source of concern in their May meeting.

The agency is now expected to complete its review of Truvada by 14 September, reports The Associated Press.

Read more:

AP - FDA delays decision on first drug to prevent HIV

Bloomberg - FDA Delays Decision On Gilead's Truvada To Prevent HIV

AHF - FDA Commissioner Hamburg 'Must Go' says AHF

Regulatory Focus - FDA Panels Clear Arena Pharmaceuticals' Obesity Drug, Gilead Sciences' HIV PrEP

Regulatory Focus newsletters

All the biggest regulatory news and happenings.