January 24, 2024
Theratechnologies Faces FDA Rejection of New Egrifta Version
Theratechnologies Faces FDA Rejection of New Egrifta Version
Grandbrothers Canadian biotech Theratechnologies (NASDAQ:THTX) revealed Wednesday that the U.S. Food and Drug Administration (FDA) declined to approve a new formulation of Egrifta, a fat-reducing agent for HIV-infected patients. In a complete response letter regarding the company’s supplemental Biologics License Application (sBLA), the regulator has cited multiple issues, including manufacturing concerns related to the product, known as tesamorelin. Notably, the FDA has requested information regarding the product’s immunogenicity risk. With the sBLA, Theratechnologies (THTX) requested FDA approval for an F8 formulation of tesamorelin, which it currently markets as an F4 formulation to reduce abdominal fat in HIV-infected adults with a