Under the marketing authorisation application (MAA) submitted to the European Medicines Agency (EMA), the company has asked the regulator to review the potential use of fostemsavir in combination with other antiretrovirals for treating HIV-1.
The approval is being sought for the treatment of people whose HIV-1 infection is multidrug-resistant and for whom it is not possible to construct a suppressive antiviral regimen owing to resistance, intolerance or safety factors.
ViiV Healthcare had secured accelerated assessment for its marketing authorisation application from the EMA’s Committee for Medicinal Products for Human Use (CHMP).
ViiV Healthcare CEO Deborah Waterhouse said: “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.”
Submission of the fostemsavir MAA is backed by the findings from a phase 3 trial called BRIGHTE held in heavily treatment-experienced people having multidrug-resistant HIV.
In July 2019, ViiV Healthcare reported that the week 96 data from the two-cohort late-stage trial showed that the HIV-1 drug candidate continued to improve virologic suppression and immunologic response.
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 multidrug-resistant HIV who are in need of new treatment options.
“Developing this medicine exemplifies ViiV’s mission and commitment to ensuring that no person living with HIV is left behind.”
In December 2019, ViiV Healthcare submitted a new drug application (NDA) for fostemsavir to the US Food and Drug Administration (FDA). The HIV-1 drug candidate was previously given the FDA Fast Track and Breakthrough Therapy designations.
The specialist HIV company, which is owned by GSK, Pfizer, and Shionogi, expects to submit regulatory applications for fostemsavir in the coming months to other global agencies.