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Mavyret Approval History

  • FDA approved: Yes (First approved August 3rd, 2017)
  • Brand name: Mavyret
  • Generic name: glecaprevir and pibrentasvir
  • Dosage form: Tablets
  • Company: AbbVie Inc.
  • Treatment for: Hepatitis C

Mavyret (glecaprevir/pibrentasvir) is a fixed-dose combination of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, indicated for the treatment of all major genotypes (GT1-6) of chronic hepatitis C.

Development History and FDA Approval Process for Mavyret

DateArticle
Aug  3, 2017Approval FDA Approves Mavyret (glecaprevir and pibrentasvir) for Hepatitis C
Apr 20, 2017AbbVie's Investigational, Pan-Genotypic, Ribavirin-free Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved 99 Percent SVR(12) Rate in Chronic Hepatitis C Patients with Compensated Cirrhosis
Feb  2, 2017U.S. FDA Grants Priority Review to AbbVie for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)
Dec 19, 2016AbbVie Submits NDA to FDA for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C
Nov 11, 2016Eight Weeks of Treatment with AbbVie's Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved High SVR Rates Across All Major Genotypes of Chronic Hepatitis C

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