Theratechnologies Submits sBLA for Trogarzo® Intramuscular (IM) Method of Administration to FDA

Theratechnologies Inc. announced that the Company has filed a supplemental Biologics License Application (sBLA) for an intramuscular (IM) method of administration for the maintenance dose of Trogarzo® (ibalizumab-uiyk) to the United States Food and Drug Administration (FDA) for review. In the U.S., Trogarzo®, in combination with other antiretrovirals (ARVs), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current ARV regimen. The Trogarzo® IM sBLA submission follows the recent FDA approval of the Company?s Labelling Prior Approval Supplement to include a 2,000-mg intravenous (IV) push loading dose, which can now be delivered in as little as 90 seconds and no longer requires treatment to be initiated in specialized infusion clinics.

The potential addition of an entirely new method of administration for the maintenance dose via a rapid IM injection every two weeks could further simplify the Trogarzo® treatment regimen. In accordance with the FDA?s filing review period, Theratechnologies expects to receive an acknowledgment letter of the sBLA application within 30 days along with a Prescription Drug User Fee Act (PDUFA) goal date. Trogarzo® (ibalizumab-uiyk) is a long-acting, CD4-directed, post-attachment HIV-1 inhibitor.

In the United States, Trogarzo®, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen. Trogarzo® is not approved in Canada. Trogarzo® is administered by intravenous (IV) infusion as a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every two weeks after dilution in 250 mL of 0.9% Sodium Chloride Injection, USP.

The Trogarzo® loading dose can also be administered as an undiluted IV push over 90 seconds, and the maintenance dose can be administered as an undiluted IV push over 30 seconds.