Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) is awaiting a decision from the U.S. Food and Drug Administration (FDA) regarding changes to the manufacturing environment for EGRIFTA SV®, a therapy used to reduce excess abdominal fat in HIV-infected patients with lipodystrophy. The company submitted a Prior Approval Supplement (PAS) to the FDA in December 2024, detailing the changes.
Regulatory Review and Potential Supply Gap
The FDA's standard review process for a PAS typically takes four months. Approval is required before Theratechnologies can distribute newly manufactured batches of EGRIFTA SV®. Current inventory levels are expected to meet patient demand until mid-January 2025. This timeline creates a potential supply gap if the FDA review extends beyond this period.
Discussions with FDA to Expedite Approval
To mitigate the risk of a shortage, Theratechnologies is actively engaged in discussions with the relevant FDA divisions. The goal is to expedite the review and approval process for the PAS, ensuring a continuous supply of EGRIFTA SV® to patients. However, there is no guarantee that the FDA will accelerate the review timeline.
Resumption of Production
Production of EGRIFTA SV® has resumed following a voluntary shutdown at the contract manufacturer's facility to address observations from a prior FDA inspection. One new batch has completed quality control and is ready for release pending FDA approval of the PAS. Two additional batches are currently in production.
Financial Implications and Market Exclusivity
Any disruption in the supply of EGRIFTA SV® could have financial implications for Theratechnologies. In 2022, EGRIFTA SV® generated $37.4 million in revenue. A supply shortage could impact quarterly earnings and potentially lead to patient attrition. EGRIFTA SV® is exclusively distributed in the United States, making the U.S. market particularly vulnerable to any supply chain disruptions.
Forward-Looking Statements and Risk Factors
Theratechnologies has cautioned investors about relying too heavily on forward-looking statements, as actual results may vary. Several assumptions underlie these statements, including the PAS meeting FDA regulatory requirements, the FDA approving the PAS before mid-January 2025, and market demand for EGRIFTA SV® remaining unaffected. Risks and uncertainties include potential delays in filing the PAS, rejection of the PAS, and decreased demand for EGRIFTA SV® due to the risk of shortage.
