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ViiV Healthcare Submits NDA To FDA For Fostemsavir On HIV-1 Infection

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, completed submission of a New Drug Application to the US Food and Drug Administration seeking approval of fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV-1 infection.

Fostemsavir is being developed for use in combination with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are unable to form a suppressive regimen due to resistance, intolerance or safety considerations.

ViiV Healthcare plans to submit regulatory applications for fostemsavir to the European Medicines Agency and other global agencies in the coming months.

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