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ViiV Healthcare Announces FDA's Priority Review Designation For Cabotegravir

ViiV Healthcare announced the FDA has accepted and granted priority review for a New Drug Application for investigational cabotegravir long-acting for pre-exposure prophylaxis, or PrEP. The target approval date is 24 January 2022.

If approved, cabotegravir would be the first, long-acting therapy for the prevention of HIV for individuals at risk of sexually acquired HIV-1, who have a negative HIV-1 test prior to initiation, the company noted.

ViiV Healthcare said it will begin submissions of cabotegravir long-acting for PrEP to other regulatory authorities by the end of 2021.

ViiV Healthcare is a specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi as shareholders.

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