FDA releases HIV combo drug guidance

FDA released a draft guidance document on an expedited review process for approving fixed-dose combinations (FDCs) of already approved HIV drugs and new co-packaging of existing therapies that could be reviewed for approval. Co-packages are multiple pills in one package, while FDCs are one pill that contains multiple drugs. FDA said the goal of having FDC or co-packaged HIV products is to "simplify regimens to allow for easier distribution and improved patient adherence, particularly in resource poor settings."

The guidance also includes examples of drug combinations considered acceptable and unacceptable for FDCs or co-packaging. FDA said that although 20 drugs are approved in the U.S. to treat HIV, only a few are approved for use as FDC products, and none is approved as a co-packaged product. Acting FDA Commissioner Crawford also announced that FDA is evaluating whether the agency can waive or reduce user fees for products reviewed under this rapid review process. ...