Dec 21 (Reuters) - GlaxoSmithKline's HIV drugs
division ViiV Healthcare said on Saturday that the U.S. Food and
Drug Administration declined to approve its long acting HIV
injection.
ViiV, in which Pfizer and Shionogi have
small stakes, said it received a so-called complete response
letter (CRL) from the FDA in which the regulator questioned the
treatment's chemistry, manufacturing and controls process, but
not its safety.
The monthly injection to suppress the virus that causes AIDS
was aimed as an alternative to daily pills.
The unit of the British drugmaker, which is challenging HIV
drug market leader Gilead Sciences, said it will work
with the FDA to determine the next steps for the new drug
application.
A GSK spokesman said it was not yet clear by when ViiV would
be able to address the FDA's concerns.
The CRL for the Cabenuva injection, containing two active
ingredients cabotegravir and Janssen's rilpivirine, follows U.S.
market approval in April for its once-a-day pill Dovato, also a
two-drug combination.
The injection has previously proven to be as effective as
standard daily pills with three active ingredients when
administered monthly and also once every two months.
U.S. drugmaker Gilead dominates the HIV market and it will
keep up the pressure with fast-growing Biktarvy, which was
approved early last year.
(Reporting by Kanishka Singh in Bengaluru; Editing by Mark
Potter and Ros Russell)