AbbVie announced the U.S. Food and Drug Administration (FDA) approved MAVYRET (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). MAVYRET is an 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment. Up to 95 percent of HCV patients in the U.S. may be eligible for treatment with MAVYRET, including patients with compensated cirrhosis or without cirrhosis and those with limited treatment options, such as patients with chronic kidney disease (CKD).
"With MAVYRET, physicians and patients now have a treatment option that is highly effective and has the potential to cure the majority of HCV patients in as short as 8 weeks, regardless of genotype," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "The approval of MAVYRET demonstrates AbbVie's commitment to advancing science to help address unmet needs by delivering a new cure for patients who historically had limited treatment options, including those with genotype 3 HCV, individuals with CKD and certain DAA failure patients."
Approximately 3.4 million Americans are chronically infected with HCV. Additionally, HCV is common among people with severe CKD, with an estimated more than 500,000ⱡ people having both chronic HCV and CKD. MAVYRET was designed to deliver a cure across all major genotypes and specific treatment challenges, such as patients with severe CKD, and GT1 patients not cured by a NS5A inhibitor or a NS3/4A protease inhibitor (PI) direct-acting antiviral (DAA) treatment, but not both. MAVYRET combines two new DAAs that target and inhibit proteins essential for the replication of the hepatitis C virus.
The approval of MAVYRET is supported by data from nine 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.
Approval of MAVYRET follows an FDA-granted Breakthrough Therapy Designation for the treatment of GT1 HCV patients who were not cured with prior DAA therapy, as well as Priority Review. According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of therapies for serious or life-threatening conditions, which may offer substantial improvement over available therapies.
AbbVie's pan-genotypic regimen was also recently granted marketing authorization by the European Commission. AbbVie's treatment is now licensed for use in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
MAVYRET is approved by FDA for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6). MAVYRET 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, taken with food.
MAVYRET is an eight-week, pan-genotypic option for patients without cirrhosis and who are new to treatment, who comprise the majority of people living with HCV. MAVYRET is also approved as a treatment for patients with specific treatment challenges, including those (GT1) not cured by prior treatment experience to either a protease inhibitor or NS5A inhibitor (but not both), and in patients with limited treatment options, such as those with severe chronic kidney disease (CKD) or those with genotype 3 chronic HCV. MAVYRET is a pan-genotypic treatment approved for use in patients across all stages of CKD.
Glecaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors.