AbbVie Announces Approval of MAVIRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) in Japan
- MAVIRET is the first and only 8-week treatment for genotype 1 and 2 hepatitis C virus (HCV) infected patients without cirrhosis and who are new to DAA treatment* in Japan
- Approval is supported by a 99 percent virologic cure** rate in these patients, who comprise the majority of people living with HCV (1,2)
- AbbVie's pan-genotypic, ribavirin-free treatment was recently approved for use in the European Union and United States
- Japan has one of the highest rates of HCV infection in the industrialized world (2,3)
NORTH CHICAGO, Ill., Sept. 27, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved 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 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
"New pan-genotypic, ribavirin-free treatments like MAVIRET that have a short treatment duration have the potential to become a first-line HCV treatment option and will also be fundamental to addressing challenges that remain in the care of this serious and complex disease in Japan," said Hiromitsu Kumada, M.D., Director General, Department of Hepatology, Toranomon Hospital Kajigaya, Kanagawa, Japan. "High cure rates were shown in dedicated clinical trials with MAVIRET in Japanese patients, as well as a favorable tolerability profile, demonstrating the potential of MAVIRET to meet evolving unmet needs for both patients and physicians."
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 and 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
"The human, social and economic burden of HCV to individuals in Japan can be significant as the disease progresses to the later stages," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "AbbVie is committed to working with health authorities to get MAVIRET to physicians and patients as quickly as possible, so that the opportunity for virologic cure in as short as 8 weeks may be a reality for the majority of people living with HCV."
Authorization 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 and 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 efficacy of MAVIRET.
Approval of MAVIRET follows priority review, designated by the Japanese MHLW 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.
**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.
- MAVIRET is the first and only 8-week treatment for genotype 1 and 2 hepatitis C virus (HCV) infected patients without cirrhosis and who are new to DAA treatment* in Japan
- Approval is supported by a 99 percent virologic cure** rate in these patients, who comprise the majority of people living with HCV (1,2)
- AbbVie's pan-genotypic, ribavirin-free treatment was recently approved for use in the European Union and United States
- Japan has one of the highest rates of HCV infection in the industrialized world (2,3)
NORTH CHICAGO, Ill., Sept. 27, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved 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 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
"New pan-genotypic, ribavirin-free treatments like MAVIRET that have a short treatment duration have the potential to become a first-line HCV treatment option and will also be fundamental to addressing challenges that remain in the care of this serious and complex disease in Japan," said Hiromitsu Kumada, M.D., Director General, Department of Hepatology, Toranomon Hospital Kajigaya, Kanagawa, Japan. "High cure rates were shown in dedicated clinical trials with MAVIRET in Japanese patients, as well as a favorable tolerability profile, demonstrating the potential of MAVIRET to meet evolving unmet needs for both patients and physicians."
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 and 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
"The human, social and economic burden of HCV to individuals in Japan can be significant as the disease progresses to the later stages," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "AbbVie is committed to working with health authorities to get MAVIRET to physicians and patients as quickly as possible, so that the opportunity for virologic cure in as short as 8 weeks may be a reality for the majority of people living with HCV."
Authorization 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 and 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 efficacy of MAVIRET.
Approval of MAVIRET follows priority review, designated by the Japanese MHLW 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.
**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.
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.
No comments:
Post a Comment