Theratechnologies (THTX) announced the resubmission of its supplemental Biologics License Application, sBLA, to the U.S. Food and Drug Administration, FDA, for the F8 formulation of tesamorelin, the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. Theratechnologies has filed the resubmission to address concerns raised in the FDA’s Complete Response Letter, CRL, to the initial F8 formulation sBLA filing. In the CRL, which was issued in January 2024, the FDA requested clarifications largely related to chemistry, manufacturing and controls, as well as further information on immunogenicity risk.
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