FDA Approves Label Update for Long-Acting HIV Treatment Cabenuva
March 24 2022 - 2:54PM
Dow Jones News
By Maria Armental
U.S. health regulators approved a label update for long-acting
HIV treatment Cabenuva, allowing patients to start the injectable
treatment without an oral lead-in phase.
Clinical data demonstrated a similar safety and efficacy profile
with and without the oral lead-in period, according to the Food and
Drug Administration.
Cabenuva is approved in the U.S. as a once-monthly or
every-two-month treatment for HIV-1 in virologically suppressed
adults on a stable antiretroviral regimen with no history of
treatment failure and with no known or suspected resistance to
cabotegravir or rilpivirine.
It was developed by Johnson & Johnson's Janssen and ViiV
Healthcare, which is majority owned by GlaxoSmithKline PLC.
Write to Maria Armental at maria.armental@wsj.com
(END) Dow Jones Newswires
March 24, 2022 15:39 ET (19:39 GMT)
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