FDA setback for ViiV Healthcare's cabotegravir and rilpivirine long-acting regimen

HIV specialist company ViiV Healthcare has received a complete response letter (CRL) from the US Food and Drug Administration regarding its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults.

The reasons given in the CRL relate to Chemistry Manufacturing and Controls (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.  ViiV Healthcare, which is majority-owned by UK pharma major GlaxoSmithKline (LSE: GSK), says it will work closely with the FDA to determine the appropriate next steps for this New Drug Application, noting that it was not yet clear by when ViiV would be able to address the FDA’s concerns.

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, a pharma unit of US healthcare giant Johnson & Johnson (NYSE: JNJ). The cabotegravir and rilpivirine long-acting regimen is an investigational product and not approved anywhere in the world.