US: GSK (ViiV) – HIV monthly injection approved by FDA

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(Reuters) – The US Food and Drug Administration on Thursday approved a long-acting HIV injection from British drugmaker GlaxoSmithKline’s HIV treatment division, ViiV Healthcare.

“This is the first FDA-approved injectable, complete regimen for HIV-infected adults that is administered once a month,” the FDA said in a statement.

ViiV, in which Pfizer Inc and Shionogi & Co Ltd have small stakes, said that the HIV injection, Cabenuva, will be shipped to wholesalers and specialty distributors in the United States in February.

The monthly injection to suppress the virus that causes AIDS is aimed as an alternative to daily pills.

The Cabenuva injection contains two active ingredients, cabotegravir and Janssen’s rilpivirine, and has previously proven as effective as standard daily pills that have three active ingredients, when given monthly.

The FDA in December 2019 declined to approve the long-acting injection, and questioned the treatment’s manufacturing process, but not its safety.

ViiV won approval for Cabenuva from the Canadian health regulator in March last year.

-Aishwarya Nair in Bengaluru


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