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GSK, Pfizer Backed Long-Acting HIV Med Under FDA Priority Review As Preventative Option

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  • The FDA has accepted and granted Priority Review to ViiV Healthcare's marketing application seeking approval for injectable cabotegravir long-acting for pre-exposure prophylaxis (PrEP).

  • The priority review designation sets ViiV up for a decision from the agency by January 24, 2022.

  • If approved, it'd be the first long-acting PrEP drug and would challenge medicines from Gilead Sciences Inc (NASDAQ: GILD).

  • ViiV Healthcare is a joint venture between GlaxoSmithKline plc (NYSE: GSK), Pfizer Inc (NYSE: PFE), and Shionogi.

  • ViiV Healthcare will initiate submissions of cabotegravir long-acting for PrEP to other regulatory authorities by the end of 2021

  • Related content: Benzinga's Full FDA Calendar.

  • Price Action: PFE stock is down 1.77% at $42.80, and GSK stock is down 0.94% at $38.14 during the market session on the last check Tuesday.

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