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EC Grants AbbVie’s MAVIRET Marketing Authorization for the Treatment of Chronic Hepatitis C

Yuvraj_pawp by Yuvraj_pawp
28th July 2017
in Europe, News

AbbVie , a global biopharmaceutical company announced that the EC has granted marketing authorization for MAVIRETĀ® (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). MAVIRET is a new 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment,* who comprise the majority of the 71 million people living with HCV globally.

“MAVIRET represents an innovation in HCV care as an 8-week, pan-genotypic option that combines two distinct antiviral agents and has high efficacy even against most genotypes commonly associated with resistance to treatment,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “This new treatment advancement has the potential to meet the diverse needs of patients in as short as 8 weeks across Europe.”


MAVIRET is also indicated for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD) or those with genotype 3 (GT3) chronic HCV infection.1 MAVIRET is a pan-genotypic treatment approved for use in patients across all stages of CKD.1


About MAVIRETĀ® (glecaprevir/pibrentasvir)

MAVIRETĀ® is approved in the European Union for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6). MAVIRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets.

MAVIRET is an 8-week, pan-genotypic option for patients without cirrhosis and who are new to treatment,* who comprise the majority of people living with HCV. MAVIRET is also approved as a treatment for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD) or those with genotype 3 chronic HCV infection. MAVIRET is a pan-genotypic treatment approved for use in patients across all stages of CKD.


Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.


About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com

 

For more information, please visit www.abbvie.com/HCV

 

Media
Jane Woo
+1 (847) 937-4754
jane.woo@abbvie.com


Carlos Taveras

+33 1 41 73 92 64
carlos.taveras@abbvie.com


Investor Relations

Liz Shea
+1 (847) 935-2211
liz.shea@abbvie.com

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