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Home>Enanta Announces that AbbVie’s MAVIRET™ (glecaprevir/pibrentasvir) Received Approval in Japan for the Treatment of All Major Genotypes (GT1-6) of Chronic Hepatitis C

Enanta Announces that AbbVie’s MAVIRET™ (glecaprevir/pibrentasvir) Received Approval in Japan for the Treatment of All Major Genotypes (GT1-6) of Chronic Hepatitis C

Enanta Announces that AbbVie’s MAVIRET™ (glecaprevir/pibrentasvir) Received Approval in Japan for the Treatment of All Major Genotypes (GT1-6) of Chronic Hepatitis C

09/27/2017

Enanta Announces that AbbVie’s MAVIRET™ (glecaprevir/pibrentasvir) Received Approval in Japan for the Treatment of All Major Genotypes (GT1-6) of Chronic Hepatitis C

  • MAVIRET is the first and only 8-week treatment approved in Japan for genotype 1 and 2 hepatitis C virus (HCV) infected patients without cirrhosis and who are new to DAA treatment *
  • Approval is supported by a 99 percent virologic cure ** rate in these patients, who comprise the majority of people living in Japan with HCV 1,2
  • Japan has one of the highest rates of HCV infection in the industrialized world 2,3
  • Glecaprevir, one of the two new, direct-acting antivirals (DAAs) in MAVIRET, is Enanta’s second protease inhibitor being developed and commercialized by AbbVie

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 Japanese Ministry of Health, Labour and Welfare (MHLW) approved AbbVie’s 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 the first and only 8-week treatment option in Japan for GT1 and GT2 HCV infected patients without cirrhosis and who are new to direct-acting antiviral (DAA) treatment,* including those with chronic kidney disease (CKD). These patients represent the majority of people living with HCV in Japan.2

In Japan, MAVIRET is also approved as a 12-week option for patients infected with GT3-6, patients with specific treatment challenges, including patients with compensated cirrhosis, and those with limited treatment options such as those not cured with previous DAA treatment.1

Enanta expects to receive a $15 million milestone payment from AbbVie in the quarter ending December 31, 2017, upon price reimbursement approval of MAVIRET in Japan.

“With the approval of this new, pan-genotypic treatment, the majority of the 2 million people infected with HCV in Japan will now be able to be treated in as little as eight weeks,” stated Jay R. Luly, Ph.D., President and CEO, Enanta.

Japan has one of the highest rates of HCV infection in the industrialized world, with approximately 2 million people living with the disease, 97 percent of whom are infected with GT1 or GT2 chronic HCV.2,3 Japan also has the highest prevalence of liver cancer amongst the industrialized countries, with chronic hepatitis C and its complications being the leading causes.4

This approval of MAVIRET is supported by data from the Phase 3 CERTAIN studies in Japanese patients and supplemented with registrational studies from AbbVie's global clinical development program for MAVIRET. With just 8 weeks of treatment, a 99 percent (n=226/229) SVR12 rate was achieved across GT1 and GT2 chronic HCV infected Japanese patients without cirrhosis and who were new to DAA treatment * .1 This high SVR12 rate was achieved in patients with varied patient and viral characteristics, including those with CKD.1 In patients not cured with previous DAA treatment, a 94 percent (n=31/33) SVR12 rate was achieved with 12 weeks of treatment. The most commonly reported adverse reactions were pruritus, headache, malaise and blood bilirubin increase (none of which had an incidence greater than 5 percent).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 more difficult-to-treat genotypes or baseline mutations that are commonly associated with resistance have been shown to have minimal impact on the efficacy of MAVIRET.

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