Extension granted by FDA in application for HIV/AIDS treatment.

Theratechnologies Inc. announced that it was notified by its partner, TaiMed Biologics, Inc. that the FDA will extend its review of the Biologics License Application (“BLA”) for ibalizumab. In a notice received by TaiMed from the FDA, the Prescription Drug User Fee Act (“PDUFA”) target action date has been extended to April 3, 2018. The three-month extension period is the FDA’s standard extension period.

On October 25, 2017, at the FDA’s request, TaiMed submitted additional documentation related to the manufacturing section of the BLA, and the FDA subsequently decided it constituted a major amendment that required an extension to the target action date, to provide time for a full review of the submission. The FDA did not request any additional information from TaiMed in this notice.