Ibalizumab Was Granted a Priority Rewiev by the FDA
The application for a biologics license for the ibalizumab (an investigational monoclonal antibody) was accepted by the FDA. Next winter the drug is planned to be available in the american drugstores. Potentially ibalizumab is new treatment for multidrug-resistant HIV, according to a press release.
Approximately more than 20 000 americans with HIV-positive status have treatment resistance to at least one drug. Ibalizumab may become the first ART with a brand new way 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. 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.” - the president and CEO of Theratechnologies Inc., a partner company of TaiMed Biologics, Luc Tanguay, commented the results of the research.