FDA declines to review intramuscular version of Theratechnologies’ HIV drug
27 Feb 2024
Phase 3Drug ApprovalClinical Result
Theratechnologies is facing its second HIV setback of the year after the FDA issued a refusal to file (RTF) letter in response to an application for intramuscular Trogarzo (ibalizumab-uiyk). An intravenously administered version of the monoclonal antibody antiretroviral therapy is approved to treat HIV-1 in combination with other antiretrovirals.
Last month, the agency rejected a simplified dosing form of Theratechnologies’ Egrifta SV (tesamorelin), which is used to reduce excess abdominal fat in adults with HIV and lipodystrophy.
The RTF said the application for intramuscular dosing “was not sufficiently complete to permit a substantive review” and lacked the required data “to establish the pharmacokinetic bridge between the intramuscular and the intravenous infusion route of administration of Trogarzo,” according to Theratechnologies.
Executives weren’t exactly surprised by the RTF, as intramuscular Trogarzo missed the primary endpoint of a Phase III trial comparing it with an IV infusion, failing to meet the equivalence limits.
“We were aware that the approval… could be challenging based on the results shared in October 2023 from the TMB-302 study, even though viral suppression was maintained throughout the study,” said chief medical officer Christian Marsolais. “We will now assess our options regarding this application.”
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
-Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.