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Cabenuva FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 25, 2021.

FDA Approved: Yes (First approved January 21, 2021)
Brand name: Cabenuva
Generic name: cabotegravir and rilpivirine
Dosage form: Extended-Release Injectable Suspension ( Co-Packaged)
Company: ViiV Healthcare
Treatment for: HIV Infection

Cabenuva (cabotegravir and rilpivirine) is a long-acting, injectable regimen of the HIV-1 integrase strand transfer inhibitor (INSTI) cabotegravir, and the HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older.

Development timeline for Cabenuva

DateArticle
Mar 29, 2022Approval ViiV Healthcare Announces US FDA Approval of Cabenuva (cabotegravir, rilpivirine) for Virologically Suppressed Adolescents Living with HIV Who Are 12 Years of Age or Older and Weigh at Least 35 kg
Mar 24, 2022Approval ViiV Healthcare Announces Label Update for its Long-Acting HIV Treatment, Cabenuva (cabotegravir, rilpivirine), to be Initiated With or Without an Oral Lead-In Period
Feb  1, 2022Approval ViiV Healthcare Announces US FDA Approval of Cabenuva (cabotegravir, rilpivirine) for Use Every Two Months, Expanding the Label of the First and Only Complete Long-Acting HIV Treatment
Jan 21, 2021Approval FDA Approves Cabenuva (cabotegravir and rilpivirine) Long-Acting Injectable HIV Treatment and Vocabria (cabotegravir) Oral HIV Treatment
Oct 21, 2020ViiV Healthcare Announces Analysis Showing no Antiretroviral Therapy Interruptions Due to COVID-19 Across its Clinical Development Programme for Investigational, Long-Acting Cabotegravir and Rilpivirine
Mar  9, 2020Janssen Announces Results of Phase 3 Study Demonstrating the Safety and Efficacy of Long-Acting Injectable HIV Treatment Regimen of Rilpivirine And Cabotegravir through 96 Weeks
Mar  9, 2020Janssen Announces 48-week Results of Phase 3b Study Demonstrating the Safety and Efficacy of Long-Acting Injectable HIV Treatment of Rilpivirine and Cabotegravir Administered Every Two Months
Dec 21, 2019FDA Complete Response Letter for Investigational Cabotegravir and Rilpivirine Long-Acting HIV Treatment
Aug 22, 2019Janssen Reports Positive Top-line Phase 3 Study Results of Investigational, Long-acting Injectable HIV Treatment Regimen Administered Every Two Months
Jul  8, 2019ViiV Healthcare Announces Start of First-Ever Study to Identify and Evaluate Approaches to Implementing its Once-Monthly Injectable HIV Treatment in Clinical Practice
Apr 29, 2019Janssen Announces Submission of New Drug Application to U.S. FDA For the First Monthly, Injectable, Two-Drug Regimen of Rilpivirine and Cabotegravir for Treatment of HIV

See also

Cabenuva (cabotegravir and rilpivirine) Consumer information

Further information

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