US regulators have declined ViiV Healthcare’s application to market an investigational long-acting regimen for the treatment of HIV.
The company, which is majority-owned by GlaxoSmithKline, with Pfizer and Shionogi as shareholders, has received a complete response letter (CRL) from US Food and Drug Administration for use of investigational cabotegravir and rilpivirine long-acting regimen for HIV-1 infection in virologically suppressed adults.
The reasons outlined in the CRL relate to chemistry manufacturing and controls (CMC), but 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, the firm stressed.
ViiV Healthcare said it would now work closely with the FDA to determine the appropriate next steps for this regimen’s marketing application.
Cabotegravir is an integrase strand transfer inhibitor developed by ViiV Healthcare and rilpivirine is a non-nucleoside reverse transcriptase inhibitor developed by Janssen Sciences Ireland UC.