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 Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, 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.
Approval of Maviret follows priority review, a designation by the Japanese MHLW granted to certain medicines based on the clinical usefulness of the treatment and severity of the disease. AbbVie’s pan-genotypic treatment was also recently granted marketing authorization by the European Commission and approved by the U.S. Food and Drug Administration as an 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment.
*Patients without previous treatment that included a DAA (direct-acting antiviral) NS3/4A protease inhibitor, NS5A inhibitor and/or NS5B polymerase inhibitor.
**Based on EC50 values of glecaprevir and pibrentasvir against full-length or chimeric replicons encoding NS3 or NS5A from laboratory strains and chimeric replicons from clinical isolates.1
_______________________________________________________
References:
1 Maviret [package insert]. Tokyo, Japan: AbbVie GK.
2 Yu ML, Chuang WL. Treatment of chronic hepatitis C in Asia: when East meets West. J Gastroenterol Hepatal. 2009;24(3):336-45
3 Liu GG, DiBonaventura M, Yuan Y, et al, The burden of illness for patients with viral hepatitis C: evidence from a national survey in Japan. Value Health. 2012;15(1 Suppl):565-71
4 Yatsuhashi, H. Past, Present, and Future of Viral Hepatitis C in Japan. Euroasian Journal of Hepato-Gastroenterology 6, 49-51 (2016)
(Source: Business Wire)
Follow us on Twitter and Facebook for updates on the latest pharmaceutical and biopharmaceutical manufacturing news!
Filed Under: Drug Discovery
