Theratechnologies Submits Updated Tesamorelin F8 Formulation sBLA for FDA Review
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Theratechnologies has resubmitted its supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin to the FDA. This resubmission addresses concerns from a previous Complete Response Letter. The F8 formulation aims to replace EGRIFTA SV® with a simplified dosing regimen for treating excess abdominal fat in adults with HIV and lipodystrophy.
November 26, 2024 | 12:45 pm
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Theratechnologies has resubmitted its sBLA for the F8 formulation of tesamorelin to the FDA, addressing previous concerns. This could lead to approval and market expansion if successful.
The resubmission of the sBLA indicates that Theratechnologies is addressing the FDA's concerns, which could lead to approval. Approval would allow the company to replace EGRIFTA SV® with the new F8 formulation, potentially increasing market share and revenues.
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