Theratechnologies received notification from its partner about an upcoming review from the US Food and Drug Administration about a biologics license application review.
Theratechnologies (TSX:TH) received notification from its partner TaiMed Biologics about an acceptance for review from the US Food and Drug Administration about a biologics license application review for ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1.
As quoted in the press release:
If approved, ibalizumab will be the first antiretroviral treatment (ART) with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing.
“We are excited to be one step closer to potentially bringing an important new treatment, with a new mechanism of action, to patients whose virus has become resistant to therapies in multiple classes and have limited treatment options for the long-term management of their condition,” said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc. “The granting of Priority Review status is important since it confirms that, if approved, ibalizumab would represent a significant improvement in the treatment of this serious condition,” added Mr. Tanguay.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 3, 2018, for the ibalizumab application. Priority Review status accelerates FDA review time from 10 months to a goal of six months from the day of acceptance. In addition, ibalizumab received Breakthrough Therapy designation from the FDA in 2015, which is given if a therapy may provide a substantial improvement over what is currently available to address a serious and life-threatening condition. The FDA also granted Orphan Drug designation in 2014.