Glaxo Files Marketing Application For Fostemsavir In Europe
Zacks Investment Research | Jan 12, 2020 10:26PM ET
GlaxoSmithKline plc’s (NYSE:GSK) HIV subsidiary ViiV Healthcare announced that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its first-in-class attachment inhibitor fostemsavir to treat heavily treatment-experienced adult patients with HIV-1 infection.
The company is seeking approval of fostemsavir for use in combination with other antiretroviral agents to treat adult patients with multidrug resistant HIV-1 infection, for whom it is otherwise not possible to form a suppressive regimen due to resistance, intolerance or safety considerations.
Notably, the EMA’s Committee for Medicinal Products for Human Use (CHMP) granted an accelerated assessment to the MAA filing for fostemsavir, which reduces the review time for the same.
The MAA filing was based on data from the pivotal phase III BRIGHTE study. In July 2019, Glaxo presented week-96 data from the same study at the International AIDS Society Conference on HIV Science held in Mexico City.
The new drug application for fostemsavir in the United States was filed with the FDA in December 2019.
Notably, ViiV Healthcare is an HIV company, majorly owned by Glaxo and Pfizer (NYSE:PFE) .
Shares of Glaxo have rallied 21.2% in the past year, outperforming the Zacks Investment Research
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