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Apretude FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 2, 2022.

FDA Approved: Yes (First approved December 20, 2021)
Brand name: Apretude
Generic name: cabotegravir
Dosage form: Extended-Release Injectable Suspension
Company: ViiV Healthcare
Treatment for: Pre-Exposure Prophylaxis

Apretude (cabotegravir) is a long-acting injectable integrase strand transfer inhibitor (INSTI) indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.

  • Apretude is the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option to reduce the risk of sexually acquired HIV-1. Oral medicines used for PrEP include Truvada (emtricitabine and tenofovir) and Descovy (emtricitabine and tenofovir alafenamide).
  • Apretude is indicated in at-risk adults and adolescents weighing at least 35 kg for PrEP to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating Apretude (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.
  • Apretude is administered via gluteal intramuscular injection every month for the first 2 months, then every 2 months. Oral cabotegravir (Vocabria) may be taken once daily for the month prior to receiving Apretude to assess tolerability.
  • Common adverse reactions include injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.

Development timeline for Apretude

Dec 20, 2021Approval FDA Approves Apretude (cabotegravir extended-release injectable suspension) for HIV Pre-Exposure Prophylaxis (PrEP)
Sep 28, 2021FDA Grants Priority Review to ViiV Healthcare’s New Drug Application for Cabotegravir Long-Acting for Prevention of HIV
Nov 17, 2020ViiV Healthcare Receives FDA Breakthrough Therapy Designation for Investigational, Long-Acting Cabotegravir for HIV prevention
Nov  9, 2020ViiV Healthcare Announces Investigational Injectable Cabotegravir is Superior to Oral Standard of Care for HIV Prevention in Women
Jul  7, 2020ViiV Healthcare Announces Superior Efficacy of Investigational, Long-Acting Injectable Formulation of Cabotegravir Dosed Every Two Months Over Daily Oral PrEP

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.