FDA SET TO MOVE QUICKLY ON COMBINATION ARVS

The FDA is prepared to "move swiftly" to approve applications for fixed-dose combinations of previously approved drugs to treat HIV, saying it expects to be able to expedite priority reviews and approve fast-track designations for such products.

In a guidance issued Oct. 17, "Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV," the agency encouraged sponsors to submit applications.

The guidance is intended to illuminate the application process by explaining what the FDA wants to see and discussing various considerations. The guidance highlights potential issues and offers solutions, clarifies the applicable regulatory requirements, and includes scenarios for approval, examples of effective drug combinations and examples of unacceptable drug combinations.

Promoting submissions of these combination drug packages is important to the FDA for several reasons. First, different drug combinations are essential for treating HIV. The agency pointed out that more than 20 antiretrovirals (ARVs) are approved for use in the U.S., but none have been approved as co-packaged products.

"At least three active drugs, usually from two different classes, are required to suppress the virus, allow recovery of the immune system and reduce the emergence of HIV resistance," the agency said. Combining preapproved drugs into fixed-dose combinations or co-packaging will help with efficacy and ease of patient use, the FDA said.

The guidance can be viewed at www.fda.gov/cder/guidance/6360fnl.pdf.