Gilead Gets CHMP Backing for Lenacapavir in Multi-Drug Resistant HIV
June 24 2022 - 9:03AM
Dow Jones News
By Colin Kellaher
Gilead Sciences Inc. on Friday said the European Medicines
Agency's Committee for Medicinal Products for Human Use recommended
approval of its investigational drug lenacapavir for people with
multi-drug-resistant HIV.
The recommendation covers lenacapavir for the treatment of HIV-1
infection, in combination with other antiretrovirals, in adults
with multi-drug resistant HIV-1 infection for whom it otherwise
isn't possible to construct a suppressive anti-viral regimen, the
Foster City, Calif., biopharmaceutical company said.
It expects a final decision from the European Commission, which
generally follows the CHMP's advice, later this year.
The U.S. Food and Drug Administration earlier this year rejected
Gilead's application seeking approval of lenacapavir due to issues
related to the vials in which the drug is stored. Gilead recently
said it has identified an alternative vial for lenacapavir.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 24, 2022 08:48 ET (12:48 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Mar 2024 to Apr 2024
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Apr 2023 to Apr 2024