By Marie Rosenthal, MS
The FDA declined to approve the cabotegravir (ViiV Healthcare) and rilpivirine (Endurant, Janssen Sciences) long-acting injectable regimen for treatment of HIV-1 infection in virologically suppressed adults.
The complete response letter from the FDA said the agency had concerns related to chemistry manufacturing and controls (CMC). ViiV said there were no reported safety issues related to CMC, and there is no change to the safety profile of the products used in clinical