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Mavyret Approval History

FDA Approved: Yes (First approved August 3, 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
Sep 27, 2019Approval FDA Approves Mavyret (glecaprevir/pibrentasvir) Treatment Duration of Eight Weeks for Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis Across All Genotypes
Apr 30, 2019Approval FDA Approves Mavyret (glecaprevir and pibrentasvir) as First Treatment for All Genotypes of Hepatitis C in Pediatric Patients
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

Further information

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