MONTREAL - Theratechnologies (NASDAQ:THTX) Inc. (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has issued a refusal to file letter (RTF) for the supplemental Biologics License Application (sBLA) for an intramuscular (IM) administration method of Trogarzo® (ibalizumab-uiyk). The sBLA aimed to provide a new method for the maintenance dose of Trogarzo®, which is currently administered intravenously.
The FDA determined that the application did not contain the necessary data to establish a pharmacokinetic bridge between the IM and the existing intravenous infusion routes. This decision follows the company's announcement of the sBLA submission on January 2, 2024, and the results from the TMB-302 study released in October 2023, which indicated viral suppression was maintained, though the company anticipated potential challenges with the application.
Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies, expressed disappointment in the FDA's decision but noted that the company is now evaluating its options regarding the application.
Trogarzo® is a long-acting, CD4-directed, post-attachment HIV-1 inhibitor approved in the United States for heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen. It is not approved in Canada.
The drug is administered by intravenous infusion every two weeks after an initial loading dose. Important safety information for Trogarzo® includes potential allergic reactions and the need for patients to inform healthcare providers of all medical conditions and medications.
Theratechnologies specializes in the development and commercialization of innovative therapies for unmet medical needs. The information in this article is based on a press release statement by the company. Further details about Theratechnologies can be found on the company's website and through its public filings on SEDAR+ and EDGAR.
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