FDA grants priority review to Theratechnologies’ ibalizumab


Theratechnologies (TSX:TH) has been notified by its partner, TaiMed Biologics, that the FDA has accepted for review the biologics license application for ibalizumab as a treatment for multidrug-resistant human immunodeficiency virus-1.

If approved, ibalizumab will be the first anti-retroviral treatment 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," Luc Tanguay, president and CEO of Theratechnologies, said in a statement.

"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," he added.

The FDA has set a PDUFA target action date of January 3, 2018, for the ibalizumab application. Ibalizumab received breakthrough therapy designation from the FDA in 2015 and orphan drug designation in 2014.