Therapy Areas: AIDS & HIV
ViiV Healthcare completes European regulatory filing for approval of Fostemsavir
14 January 2020 -

United States-based ViiV Healthcare has completed a regulatory filing in Europe seeking approval for Fostemsavir intended for the treatment of HIV-1 infection in adult patients having limited treatment options, it was reported yesterday.

According to the marketing authorisation application (MAA) submitted to the European Medicines Agency (EMA), the firm has asked the regulator to review the potential use of the product in combination with other antiretrovirals for treating HIV-1. The approval is intended 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 due 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.'