GSK’s ViiV Healthcare Gets Complete Response Letter from FDA Over Mfg Issues
ViiV Healthcare, a specialist HIV company majority owned by GlaxoSmithKline, with Pfizer and Shionogi as shareholders, has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its new drug application for the cabotegravir and rilpivirine long-acting regimen for the treatment of HIV-1 infection in virologically suppressed adults.
The reasons given in the CRL relate to chemistry, manufacturing and controls (CMC). The company says there have been no reported safety issues related to CMC and that there is no change to the safety profile of the products used in clinical trials to date. ViiV Healthcare says it will work closely with the FDA to determine the appropriate next steps for this new drug 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. The cabotegravir and rilpivirine long-acting regimen is an investigational product and not yet approved anywhere in the world.
Source: ViiV Healthcare