ARTICLE | Company News

FDA approves mAb for multidrug-resistant HIV

March 6, 2018 10:02 PM UTC

FDA approved Trogarzo ibalizumab-uiyk, a humanized mAb against CD4 that prevents viral entry, to treat heavily treatment-experienced patients with HIV-1 whose infections cannot be treated successfully with existing multidrug-resistant therapies. Theratechnologies Inc. (TSX:TH), which has U.S. rights to market and distribute the drug from TaiMed Biologics Inc. (TPEx:4147), gained C$2 (28%) to C$9.23 on Tuesday.

Theratechnologies said the approval is FDA's first in more than a decade for a drug with a new mechanism of action to treat HIV. The company expects to launch Trogarzo in the U.S. within six weeks at an annual wholesale acquisition cost (WAC) of $118,000...