Fostemsavir was submitted for the US FDA new drug application (NDA), and was granted FDA fast track and breakthrough therapy designations in the US
ViiV Healthcare, a joint venture between Pfizer and GlaxoSmithKline (GSK), has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its HIV drug Fostemsavir.
Fostemsavir is an investigational, attachment inhibitor developed for the treatment of HIV-1 infection, and the company has filed MAA for approval of Fostemsavir, in combination with other antiretrovirals, for the treatment of adults with multi-drug-resistant HIV-1 infection.
ViiV has secured an accelerated assessment for its Fostemsavir MAA, by the EMA’s Committee for medicinal products for human use (CHMP).
In addition, the company has submitted a new drug application (NDA) for Fostemsavir to the US Food and Drug Administration (FDA) in December 2019, and the drug has been granted FDA fast track and breakthrough therapy designations in the US.
ViiV Healthcare research and development head Kimberly Smith said: “The efficacy and safety findings from Fostemsavir’s clinical development program demonstrate its unique potential for people living with multi-drug-resistant HIV who need new treatment options.
“Developing this medicine exemplifies ViiV’s mission and commitment to ensuring that no person living with HIV is left behind. We look forward to working with the EMA to make Fostemsavir available to the people in Europe who need it.”
Regulatory approval of Fostemsavir is based on Phase 3 BRIGHTE study
The company said that it has submitted the MAA based on data from the phase 3 BRIGHTE study in 371 heavily treatment-experienced people living with multidrug-resistant HIV.
The primary endpoint analysis of the study showed the superiority of Fostemsavir compared to placebo. The most common adverse reactions include nausea and diarrhoea.
The company said that it intends to submit regulatory applications for Fostemsavir to other regulatory agencies across the world, in a few months.
ViiV Healthcare CEO Deborah Waterhouse said: “ViiV Healthcare 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.
“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.”