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GlaxoSmithKline receives HIV treatment knock-back in the USA

Glaxo's specialist HIV drugs division, in which Pfizer and Shionogi have stakes, has been developing the once-a-month injection as an alternative to daily treatments

GlaxoSmithKline PLC -

The US Food and Drug Administration (FDA) has declined to approve an HIV treatment backed by drugs giants GlaxoSmithKline PLC (LON:GSK), Pfizer and Shionogi.

ViiV Healthcare, Glaxo’s specialist HIV drugs division, received what is known as a complete response letter from the FDA regarding its application for the cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults.

On the plus side, there were no safety issues flagged by the FDA with the once-a-month injection and there is no change to the safety profile of the products used in clinical trials to date.

The FDA is, however, concerned about chemistry manufacturing and controls.

ViiV Healthcare will work closely with the FDA to determine the appropriate next steps for this new drug application.

Shares in Glaxo were down 0.8% at 1,798p in early deals.

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