(RTTNews) – GlaxoSmithKline plc (GSK.L, GSK) announced Monday that its majority-owned ViiV Healthcare, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete response letter or CRL from the US Food and Drug Administration. The CRL is for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV-1 infection in virologically suppressed adults.
The company said the reasons given in the CRL relate to Chemistry Manufacturing and Controls or CMC. 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.
Cabotegravir is an integrase strand transfer inhibitor developed by ViiV Healthcare. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor developed by Janssen Sciences Ireland UC.
GlaxoSmithKline noted that ViiV Healthcare will work closely with the FDA to determine the appropriate next steps for this New Drug Application.
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