FRANKFURT (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)