ViiV Gets FDA Priority Review for Cabotegravir Long-Acting for HIV Prevention
28 Setembro 2021 - 9:12AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 28, 2021 07:57 ET (11:57 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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