Theratechnologies Files SBLA For Trogarzo Intramuscular Method Of Administration With FDA
(RTTNews) - Biopharmaceutical company Theratechnologies Inc. (THTX, TH.TO) announced Tuesday the filing of a supplemental Biologics License Application (sBLA) for an intramuscular (IM) method of administration for the maintenance dose of Trogarzo (ibalizumab-uiyk) to the U.S. Food and Drug Administration (FDA) for review.
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.
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