U.S. FDA Approves Streamlined Process for Initiating HIV Therapy with CABENUVA (cabotegravir and rilpivirine), the First and Only Complete Long-Acting Injectable HIV Treatment

TITUSVILLE, N.J., March 24, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved a label update for CABENUVA (cabotegravir and rilpivirine), giving healthcare professionals and people living with human immunodeficiency virus (HIV-1) in the U.S. the option to start this once-monthly or every-two-month injectable treatment without the need for the oral lead-in phase (daily cabotegravir and rilpivirine tablets, taken for one month prior to initiation of cabotegravir and rilpivirine injections).1 Clinical data demonstrated the regimen displays a similar safety and efficacy profile both with and without an oral lead-in period.2 CABENUVA was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen’s decades-long commitment to combatting HIV. “We have a proven track record of bringing innovative therapies to people living with HIV, and our commitment to ushering in new scientific advancements has not wavered,” said James Merson, Ph.D., Global Therapeutic Area Head, Infectious Diseases, Janssen Research & Development, LLC. “With this expanded label milestone, Janssen is offering an additional pathway that simplifies the treatment landscape for people living with HIV in the U.S. who are prescribed CABENUVA therapy.” CABENUVA is the first and only complete long-acting HIV treatment regimen and is approved in the U.S. as a once-monthly or every-two-month tre...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news