GSK: FDA declines to approve new HIV-1 treatment
(CercleFinance.com) - GSK HIV unit ViiV Healthcare said on Monday the U.
S. Food and Drug Administration declined to approve its long-acting treatment of HIV-1 infection in virologically suppressed adults.
In a so-called "complete response letter," the FDA questioned the treatment's chemistry, manufacturing and controls process, but not its safety profile, the company said.
ViiV said it will work with the FDA to determine the next steps for the application of this new drug, a combination of cabotegravir and rilpivirine.
Copyright (c) 2019 CercleFinance.com. All rights reserved.
S. Food and Drug Administration declined to approve its long-acting treatment of HIV-1 infection in virologically suppressed adults.
In a so-called "complete response letter," the FDA questioned the treatment's chemistry, manufacturing and controls process, but not its safety profile, the company said.
ViiV said it will work with the FDA to determine the next steps for the application of this new drug, a combination of cabotegravir and rilpivirine.
Copyright (c) 2019 CercleFinance.com. All rights reserved.