Edurant FDA Approval History
Last updated by Judith Stewart, BPharm on March 18, 2024.
FDA Approved: Yes (First approved May 20, 2011)
Brand name: Edurant
Generic name: rilpivirine
Dosage form: Tablets and Tablets for Oral Suspension
Company: Janssen Pharmaceuticals, Inc.
Treatment for: HIV Infection
Edurant (rilpivirine) is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) used for the treatment of HIV-1 infection.
- Edurant is indicated:
- in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 2 years of age and older and weighing at least 14 kg with HIV-1 RNA less than or equal to 100,000 copies/mL.
Limitations of Use: More Edurant treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to Edurant treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL.
- Edurant is indicated in combination with Vocabria (cabotegravir), for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
Development timeline for Edurant
Further information
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