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 condition called lipodystrophy (abnormal distribution of fat).
- Despite the setback, Theratechnologies (THTX) said its F4 formulation, Egrifta SV, will continue to be available on the market.
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