Complete Response Letter Issued From U.S. FDA For Investigational Long-Acting HIV Regimen

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) in response to ViiV Healthcare's (ViiV) New Drug Application for the two-drug long-acting (LA) injectable regimen of ViiV's cabotegravir and Janssen's rilpivirine for the treatment of HIV-1 infection in adults. The regimen was co-developed as part of a collaboration between Janssen and ViiV.

The reasons given in the CRL relate to Chemistry, Manufacturing, and Controls (CMC). There have been no reported safety issues related to CMC, and the . . .