Janssen Announces 96-week Results of Phase 3b Study Demonstrating the Continued Safety and Efficacy of Long-acting HIV Treatment of Rilpivirine and Cabotegravir

CORK, IRELAND, March 6, 2021 – The Janssen Pharmaceutical Companies of Johnson &Johnson today presented positive long-term data from the global Phase 3b trial of the first complete, long-acting (LA), two-drug injectable regimen (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The 96-week findings of the Antiretroviral Therapy as Long-Acting Suppression Every 2 Months (ATLAS-2M) trial confirmed the primary endpoint, met at Week 48, and met the secondary endpoint, showing efficacy of both monthly dosing and every 2-month dosing over the long-term in virologically suppressed adults with HIV-1.1 These data were presented at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI). The every two-months dosing regimen is under investigation and is not approved in the U.S. or Canada. “Johnson &Johnson has been in the fight against HIV for decades – and our commitment to driving the innovation needed to help make HIV history is as strong as ever,” said Ruxandra Draghia-Akli, M.D., Ph.D., Global Head, Global Public Health Research &Development, Janssen Research &Development, LLC. “The data from the ATLAS-2M study is further evidence that this long-acting injectable regimen could offer a promising new treatment option, as appropriate, for people living with HIV – and we are extremely proud of the sci...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news

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TITUSVILLE, N.J., February 24, 2021 – The Janssen Pharmaceutical Companies of Johnson &Johnson today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) by ViiV Healthcare for the expanded use of CABENUVA (consisting of Janssen’s long-acting rilpivirine and ViiV Healthcare’s cabotegravir). The sNDA seeks to expand the CABENUVA label to include administration every two months for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in virologically suppressed adults (HIV-1 RNA less than 50 copies per mL) on a stab...
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