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
| Date | Article |
|---|
| Mar 29, 2022 | Approval 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, 2022 | Approval 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, 2022 | Approval 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, 2021 | Approval FDA Approves Cabenuva (cabotegravir and rilpivirine) Long-Acting Injectable HIV Treatment and Vocabria (cabotegravir) Oral HIV Treatment |
| Oct 21, 2020 | ViiV 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, 2020 | Janssen 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, 2020 | Janssen 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, 2019 | FDA Complete Response Letter for Investigational Cabotegravir and Rilpivirine Long-Acting HIV Treatment |
| Aug 22, 2019 | Janssen Reports Positive Top-line Phase 3 Study Results of Investigational, Long-acting Injectable HIV Treatment Regimen Administered Every Two Months |
| Jul 8, 2019 | ViiV 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, 2019 | Janssen 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 |
Further information
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