Posted by Michael Wonder on 22 Dec 2019
ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV
21 December 2019 - ViiV Healthcare, with Pfizer and Shionogi, has received a complete response letter from the US FDA 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 letter 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 will work closely with the FDA to determine the appropriate next steps for this new drug application.
