The U.S. FDA has issued a refusal to file letter for Theratechnologies' supplemental BLA for an intramuscular version of the maintenance dose of the Montreal-based company's approved HIV med, Trogarzo.
According to Theratechnologies, the RTF states that the application, which was submitted in early January, lacks the data required to establish the pharmacokinetic bridge between the intramuscular and the intravenous infusion route of administration of Trogarzo.
Trogarzo, a long-acting, CD4-directed, post-attachment HIV-1 inhibitor, was approved in 2018 for multidrug resistant HIV. The drug is administered by intravenous infusion as a single loading dose followed by a maintenance dose every two weeks.
Theratechnologies' sBLA submission follows the recent FDA approval of a simplified method of delivering the initial dose, allowing it to be delivered in as little as 90 seconds without requiring a specialized infusion clinic. With the goal of further simplifying the Trogarzo treatment regimen, Theratechnologies was hoping to get the OK for an entirely new method of administration for the maintenance dose via a rapid intramuscular injection every two weeks.
Theratechnologies expressed disappointment in the recent refusal to file letter and said it will now assess its options regarding the intramuscular application.
