Canada OKs ViiV HIV drug, post FDA rejection

March 20, 2020

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi Limited as shareholders, announced that Health Canada has approved once-monthly long-acting Cabenuva.

The drug — which has been touted as a game-changer in HIV treatment — is the first and only once-monthly, complete long-acting regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in patients who are virologically stable and suppressed.

Last December, the U.S. FDA declined the approval of Cabenuva, citing concerns about the Chemistry, Manufacturing and Controls process. No safety or efficacy concerns were noted.

Health Canada — the first to approve the injections — is basing its decision on based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies that included more than 1,100 participants from 16 countries.

Read the press release