If the monoclonal antibody is approved, it will be the first antiretroviral treatment with a new mechanism of action to be introduced in a decade. It would also be the only available therapy that doesn’t necessitate daily dosing.
The FDA set a target action date of January 3, 2018 for the application.
“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,” president & CEO Luc Tanguay said in prepared remarks. “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.”
TH shares were trading at $8.58 apiece in mid-afternoon activity, up +4.4%