Theratechnologies (THTX) said Tuesday it received US Food and Drug Administration approval of its Prior Approval Supplement to the supplemental biologics license application for Egrifta SV, or tesamorelin, used to reduce excess abdominal fat in adults with HIV and lipodystrophy.
The approval removes the need for discretionary product release, allowing the company to resume normal distribution of Egrifta SV.
The FDA also recently approved a new F8 formulation of tesamorelin, to be marketed as Egrifta WR, which will replace Egrifta SV in the US.
Safety considerations include unestablished long-term cardiovascular effects, a weight-neutral profile, and no evidence of improved adherence to antiretroviral therapy, the company said.
Shares of Theratechnologies were up more than 5% in recent trading.
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