The U.S. FDA declined the approval of ViiV Healthcare's Cabenuva, the first long-acting HIV drug.
The agency's complete response letter was related to concerns about the Chemistry, Manufacturing and Controls process, not the safety or efficacy of the drug. According to a ViiV press release, "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."
The new pill-free treatment from ViiV, the specialist company majority owned by GSK, with Pfizer and Shionogi Limited as shareholders, would require monthly injections of two common HIV drugs, cabotegravir and rilpivirine, delivered in a doctor’s office or clinic.
Read the press release
