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GSK-backed ViiV files for EMA approval of fostemsavir to treat HIV-1

ViiV Healthcare Ltd. filed an application with the European Medicines Agency seeking approval of its medicine fostemsavir to treat HIV-1 patients who no longer respond to other therapies.

The U.K.-based company — majority-owned by GlaxoSmithKline PLC, with Pfizer Inc. and Shionogi & Co. Ltd. as shareholders — is developing fostemsavir for use in combination with other antiretroviral drugs to treat adults with multidrug-resistant HIV-1 infection who do not show virus suppression due to resistance or intolerance to other drugs.

The EMA has granted fostemsavir an accelerated assessment, which reduces the time taken to review products for marketing approval.

On Dec. 5, 2019, ViiV filed for approval of the drug with the U.S. Food and Drug Administration. The FDA has granted the medicine fast-track and breakthrough-therapy tags to facilitate and speed up its development.

In July 2019, data from the late-stage Brighte study showed that fostemsavir helped suppress the HIV-1 virus in patients who had been heavily treated in the past.