Theratechnologies, a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced a risk of a temporary supply disruption for EGRIFTA SV® (tesamorelin for injection) in early 2025 caused by an unexpected voluntary shutdown of the Company’s contract manufacturer’s facility following an inspection by the US Food and Drug Administration (FDA), as well as the FDA review timeline to resume distribution of the product.
“We are collaborating closely with our manufacturer and other stakeholders and will continue to work with the FDA to resume production of EGRIFTA SV®,” said Paul Lévesque President and CEO at Theratechnologies. “We remain confident that we will avoid any impact on patients in 2025.”
The Company will implement measures to carefully manage the inventory levels of EGRIFTA SV® to meet patient demand until early January 2025, and estimates that these measures will result in a shortfall of approximately US$1.6 million in revenue from EGRIFTA SV® for its fiscal year 2024.
“Although this situation will affect revenues in the fourth quarter of 2024, we remain on track to deliver a strong Adjusted EBITDA in the current fiscal year and will be providing more details as part of the release of our third quarter results in October,” concluded Lévesque.
Background:
Theratechnologies’ manufacturer of EGRIFTA SV® recently implemented a three-month voluntary shutdown of its facility to address observations by the FDA Office of Compliance, following a plant inspection. The observations issued by the FDA are not related to the manufacturing process of EGRIFTA SV®, but rather related to the manufacturing environment of the facility. The manufacturer is finalizing its remediation measures and has confirmed to the Company that it plans to resume activities by mid-October. Based on these timelines, a batch of EGRIFTA SV® is currently scheduled to be manufactured on October 21, 2024.
In order to resume distribution of EGRIFTA SV®, Theratechnologies was requested by the FDA to file a Prior Approval Supplement (PAS) describing the changes made by its manufacturer. The Company expects to file the PAS on or around the manufacturing date. A PAS is reviewed by the FDA within four months of receipt.
The Company will update the market on any further material developments.
EGRIFTA SV® is distributed in the United States only.
