SGIOY - ViiV Janssen's cabotegravir + rilpivirine wins marketing approval in Europe for HIV treatment
ViiV Healthcare announces the authorization of Vocabria (cabotegravir injection and tablets) in combination with Johnson & Johnson (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 (GSK), Pfizer (PFE) and Shionogi (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
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ViiV, Janssen's cabotegravir + rilpivirine wins marketing approval in Europe for HIV treatment