FDA grants priority review to MDR HIV treatment ibalizumab

The FDA recently accepted a Biologics License Application for TaiMed Biologics’ investigational monoclonal antibody ibalizumab, which is being developed as a potential new treatment for multidrug-resistant HIV, according to a press release.

Ibalizumab was granted priority review with a Prescription Drug User Free Act action date of January 3, 2018, the release said.

The Biologics License Application, submitted on May 3, is based on 24-week data from a phase 3 trial that showed ibalizumab — administered intravenously once every 2 weeks in combination with an optimized background regimen — was well-tolerated and reduced viral load in treatment-experienced patients with advanced HIV disease and high pre-existing levels of drug resistance. If approved, it will be the first ART with a new mechanism of action in almost 10 years and the only treatment that does not need to be taken daily.

“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 Inc., a partner company of TaiMed Biologics, said in the release. “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.”

According to the release, approximately 20,000 to 25,000 people living with HIV in the United States have a virus that is resistant to at least one drug out of the three different classes of therapies. Among these patients, about 12,000 experience virological failure over 48 weeks of treatment.

The FDA previously granted ibalizumab with Breakthrough Therapy designation in 2015 and Orphan Drug designation in 2014.

Disclosure: Tanguay is president and CEO of Theratechnologies Inc.