Theratechnologies submits sBLA for Trogarzo IM method of administration to FDA

Theratechnologies 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 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 intramuscular method of administration, if approved for the maintenance dose, will give patients and their health care providers more options for Trogarzo treatment and without the need for regular IV placement,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. “Our vision through the introduction of IV push administration and, hopefully soon, IM administration, is that Trogarzo treatment will be a less invasive and more convenient proposition for heavily treatment-experienced adults with HIV, a population that has long had limited non-oral treatment options.”