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Cabenva (cabotegravir/rilpivirine Resubmitted for FDA Approval
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Cabenuva is ViiV Healthcare's first long-acting injectable and combines the integrase strand transfer inhibitor (INSTI) cabotegravir, with the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine.
. It is the first and only once-monthly, complete long-acting regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral (ARV) regimen in those who are virologically stable and suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]). 1
GSK says it is within weeks of resubmitting HIV injection Cabenuva
(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.
Reported resubmitted in July 2p GSK press release on 2nd quarter 2020:
https://www.gsk.com/media/6064/q2-2020-results-announcement.pdf
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