GlaxoSmithKilne’s HIV company ViiV Healthcare has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval of fostemsavir.
The drug, an investigational, first-in-class attachment inhibitor, is seeking indication for the treatment of HIV-1 infection when used in combination with other antiretrovirals.
The company said that the submission is for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen due to resistance, intolerance or safety considerations.
In addition to the submission, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has granted an accelerated assessment for the fostemsavir MAA, which will be awarded if the CHMP determines the product is of major interest for public health and therapeutic innovation.
The drug in question is an investigational prodrug of temsavir, and a first-in-class HIV-1 attachment inhibitor that works by binding directly to the glycoprotein 120 subunit on the surface of the virus.
The efficacy of the therapy is based on 96-week data from the phase III, partially-randomised, international, double-blind, placebo-controlled BRIGHTE study, in which it showed superiority to placebo.
The company is “proud to be sending a regulatory submission to the EMA for a medicine that is intended for people living with HIV who have been unable to suppress their virus and have few treatment options remaining” said Deborah Waterhouse, chief executive officer.
She continued, “Treatment regimens may fail due to the constantly changing nature of HIV and individuals can be left with limited options due to challenges with tolerability, safety and drug-to-drug interactions.
“Although these individuals make up a small percentage of the total number of people who live with HIV, their unmet treatment needs are life-threatening and we are committed to addressing them through innovative new medicines like fostemsavir.”
The treatment is not yet approved by regulatory authorities anywhere in the world.