Gilead Sciences (GILD) said Tuesday that the US Food and Drug Administration has accepted its new drug application submissions for lenacapavir for the prevention of HIV as pre-exposure prophylaxis.
The biopharmaceutical company said the FDA will review the applications under priority review and has assigned a Prescription Drug User Fee Act target action date of June 19.
Lenacapavir received FDA breakthrough therapy designation in October, which is intended to expedite the development and regulatory review of certain investigational treatments, the company said.
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