Theratechnologies receives FDA approval of PAS for EGRIFTA SV sBLA

Theratechnologies (THTX) announced that the U.S. Food and Drug Administration, FDA, has approved the Company’s Prior Approval Supplement, PAS, to the supplemental biologics license application, sBLA, for EGRIFTA SV. Approval of the PAS removes any regulatory requirement for discretionary product release, thereby allowing Theratechnologies to resume regular distribution of EGRIFTA SV. The FDA also recently approved the new F8 formulation of tesamorelin for injection, which is set to replace EGRIFTA SV and will be marketed in the US as EGRIFTA WR. “Securing FDA approval of the Prior Approval Supplement for the EGRIFTA SV sBLA closes a chapter of supply uncertainty and we are pleased to return to normal supply conditions,” said Paul Levesque, President and CEO of Theratechnologies. “Now that we have also obtained approval of EGRIFTA WR, we look forward to transitioning patients to this more convenient formulation, which we have designed to improve the patient experience.”