Theratechnologies Receives Complete Response Letter on the sBLA of Tesamorelin for Abdominal Fat Reduction in HIV and Lipodystrophy Patients
Shots:
- Theratechnologies has received a Complete Response Letter (CRL) from the US FDA on its sBLA of tesamorelin’s F8 formulation for excess abdominal fat reduction in HIV and lipodystrophy patients
- The CRL raised concerns regarding chemistry and manufacturing & controls (CMC) incl. microbiology, assays, impurities & stability for both the lyophilized and the final reconstituted drug. The US FDA has also requested data demonstrating the impact of the proposed formulation on immunogenicity risk
- The issued CRL does not affect the commercial availability of EGRIFTA SV (F4 formulation of tesamorelin) for excess abdominal fat reduction in adults with HIV and lipodystrophy
Ref: Theratechnologies | Image: Theratechnologies
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
