Enanta Announces European Commission Grants AbbVie Marketing Authorization For MAVIRET® (glecaprevir/pibrentasvir) For The Treatment Of Chronic Hepatitis C In All Major Genotypes (GT1-6)

Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that the European Commission (EC) has granted AbbVie marketing authorization for MAVIRET® (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 new to treatment*, who comprise the majority of the estimated 71 million people worldwide living with HCV. 2,3

MAVIRET is also indicated for patients with specific treatment challenges, including those with compensated cirrhosis across all major HCV 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. 1 MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of CKD. 1

Following this marketing authorization of MAVIRET in the European Union (E.U.), Enanta expects to receive a $25 million milestone payment from AbbVie.

"This authorization means that MAVIRET now has the opportunity to address the majority of HCV patients in Europe with a simple, pan-genotypic, 8-week treatment option, and is also approved for use in patients across all stages of CKD," stated Jay R. Luly, Ph.D., President and CEO, Enanta. "We are thrilled to have our second protease inhibitor approved and be part of this exciting new HCV regimen."

The approval of MAVIRET is supported by data from eight registrational studies in AbbVie's clinical development program, which evaluated more than 2,300 patients in 27 countries across all major HCV genotypes (GT1-6) and special populations.

EC authorization is supported by data from AbbVie's registrational studies showing a combined 97.5 percent (n=779/799)† cure** rate with just 8 weeks of treatment in GT1-6 patients without cirrhosis and new to treatment. 1 This high cure rate was achieved in patients with varied patient and viral characteristics and including those with CKD. 1 For compensated cirrhotic patients, a 98 percent (n=201/205)‡ cure rate was achieved with 12 weeks of treatment. 1 For GT3 treatment-experienced patients with or without compensated cirrhosis, a 96 percent (n=66/69) cure rate was achieved with 16 weeks of treatment. 1 In registrational studies for MAVIRET, less than 0.1 percent of patients discontinued treatment due to adverse reactions. 1 The most commonly reported adverse reactions (incidence greater than or equal to 10 percent) were headache and fatigue. 1

MAVIRET combines two new, potent ‡‡ direct-acting antivirals that target and inhibit proteins essential for the replication of the hepatitis C virus. The presence of most genotypes or baseline mutations that are commonly associated with resistance have been shown to have minimal impact on the efficacy of MAVIRET.

EC authorization follows the European Medicines Agency's review of MAVIRET under accelerated assessment, which is granted to new medicines of major public health interest. AbbVie's MAVIRET treatment is now licensed for use in all 28 member states of the E.U., as well as Iceland, Liechtenstein and Norway. AbbVie's investigational, pan-genotypic regimen has also been granted accelerated review designations by other regulatory authorities, including the U.S. Food and Drug Administration and the Japanese Ministry of Health, Labour and Welfare.

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