GlaxoSmithKline says HIV joint venture treatment rejected by FDA

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GlaxoSmithKline confirmed that its ViiV Healthcare joint venture with Pfizer and Shionogi had received a so-called complete response letter from the US Food and Drug Administration rejecting an HIV treatment.

The company said the letter regarded its application for the cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults.

'The reasons given in the complete response letter relate to chemistry manufacturing and controls, or CMC,' ViiV Healthcare said.

'There have been no reported safety issues related to CMC and there is no change to the safety profile of the products used in clinical trials to date,' it added.

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