ViiV, Janssen's cabotegravir + rilpivirine wins marketing approval in Europe for HIV

 

• ViiV Healthcare announces the authorization of Vocabria (cabotegravir injection and tablets) in combination with Johnson & Johnson (NYSE:JNJ) unit, Janssen Pharmaceuticals' Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets), in the European Union (EU), for the treatment of HIV-1 infection in adults who are virologically suppressed.
• Cabotegravir and rilpivirine injections could reduce the number of days of treatment per year from 365 down to 12 for the once-monthly, or 6 for the once every 2-months dosing regimen.
• This announcement marks the second marketing authorization of the long-acting regimen of cabotegravir and rilpivirine, with once-monthly dosing licensed by Health Canada under the brand name Cabenuva for the treatment of HIV-1 infection.
• ViiV Healthcare is the HIV-focused joint venture between GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE) and Shionogi (OTCPK:SGIOY).
• In July, ViiV Healthcare resubmitted the NDA for once-monthly dosing of cabotegravir and rilpivirine to the FDA, and further regulatory applications have been submitted and are being reviewed by other regulatory bodies worldwide.
• https://seekingalpha.com/news/3646055-viiv-janssens-cabotegravir-rilpivirine-wins-marketing-approval-in-europe-for-hiv-treatment