US FDA Approves of AbbVie's Mavret for the Treatment of Chronic Hepatitis C in All Major Genotypes.
M2 PHARMA-August 4, 2017-US FDA Approves of AbbVie's Mavret for the Treatment of Chronic Hepatitis C in All Major Genotypes
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- The US Food and Drug Administration approved US-based pharmaceutical company AbbVie's Mavret (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus infection across all major genotypes (GT1-6), US-based research and development-focused biotechnology company Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA) said.
Mavret is an eight-week, pan-genotypic treatment for patients without cirrhosis and new to treatment.
Up to 95% of HCV patients in the US may be eligible for treatment with Mavret, including patients with compensated cirrhosis or without cirrhosis, and those with limited treatment options, such as patients with chronic kidney disease.
Following this approval of Mavret in the US, Enanta expects to receive a USD 40m milestone payment from AbbVie.
Approximately 3.4m Americans are chronically infected with HCV.
Additionally, HCV is common among people with severe CKD, with more than 500,000# people in the US estimated to have both chronic HCV and CKD.
Mavret was designed to deliver a cure across all major genotypes and for specific treatment challenges, such as patients with severe CKD, and GT1 patients not cured by a NS5A inhibitor or a NS3/4A protease inhibitor in a direct-acting antiviral treatment, but not both.
Mavret combines two new DAAs that target and inhibit proteins essential for the replication of the hepatitis C virus.
The approval of Mavret 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.
AbbVie's pan-genotypic regimen also was recently granted marketing authorization by the European Commission, which means it is now licensed for use in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
Enanta's research and development efforts are currently focused on the following disease targets: non-alcoholic steatohepatitis / primary biliary cholangitis, respiratory syncytial virus and hepatitis B virus.
The company has also discovered novel protease inhibitors that have been developed as part of AbbVie's hepatitis C virus treatment regimens under a collaboration that now provides Enanta a payment stream, which it is using to fund its research and development programmes.
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|Date:||Aug 4, 2017|
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