FRANKFURT, July 2 (Reuters) - GlaxoSmithKline's HIV
business ViiV is within weeks of resubmitting its request for
approval of its long-acting injection Cabenuva to U.S. drug
regulators, ViiV's head of research said on Thursday.
ViiV executive Kimberly Smith told a media briefing that the
company would stick to its previous guidance of refiling the
request around mid-year and that this would happen "within
weeks".
The U.S. Food and Drug Administration in December declined
to approve the long acting injection, designed as an alternative
to the standard daily pills for people infected with the virus
that causes AIDS.
The FDA at the time questioned the treatment's manufacturing
process, but not its safety.
(Reporting by Ludwig Burger;Editing by Elaine Hardcastle)
Glaxosmithkline (GSK)