Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA by ViiV Healthcare for Expanded Use of CABENUVA (rilpivirine and cabotegravir) as an HIV Treatment for Use Every Two Months

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 stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. CABENUVA was approved by the FDA in January 2021 as a once-monthly, long-acting regimen for the treatment of HIV-1 infection in virologically suppressed adults.1 The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen’s 25-year commitment to make HIV history. ViiV Healthcare is the marketing authorization holder for CABENUVA in the U.S.“Today’s submission marks another important milestone on our journey to improving the lives of those living with HIV through the development of innovative new treatments,” said Brian Woodfall, M.D., Global Head, Development, Infectious Diseases, Janssen Biopharma, Inc. “First, with the introduction in the U.S. of CABENUV...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

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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 monthl...
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