ViiV Gets FDA Priority Review for Cabotegravir Long-Acting for HIV Prevention

By Colin Kellaher

ViiV Healthcare, the specialist HIV company majority owned by GlaxoSmithKline PLC, on Tuesday said the U.S. Food and Drug Administration granted priority review to its cabotegravir long-acting pre-exposure prophylaxis, or PrEP, therapy.

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

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. ViiV said the agency set a target action date of Jan. 24, 2022, for the application.

ViiV, formed in November 2009, is majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi & Co. as shareholders. The company said it plans to initiate submissions of cabotegravir long-acting for PrEP to other regulatory authorities by the end of the year.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

09-28-21 0757ET