Theratechnologies Inc. (THTX), a biopharmaceutical company, Tuesday announced the resubmission of its supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration or FDA for the F8 formulation of tesamorelin.
Tesamorelin is approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.
The F8 Formulation is bioequivalent to the original formulation of tesamorelin, or F1 Formulation, sold as EGRIFTA.
Theratechnologies expects a decision from the FDA by the end of March 2025.
In January this year, the FDA had issued a Complete Response Letter (CRL) to the initial F8 formulation sBLA filing. The regulator had requested clarifications mainly related to chemistry, manufacturing and controls (CMC), as well as further information on immunogenicity risk.
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