Enanta Pharmaceuticals Announces Sale of a Portion of Global Royalties on MAVYRET® (U.S.)/MAVIRET® (ex-U.S.) (Glecaprevir/Pibrentasvir) to OMERS Life Sciences for $200 Million
WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it has dosed the first subject in its Phase 1 clinical trial of EDP-323, a novel, oral L-protein inhibitor in development for the treatment of respiratory syncytial virus (RSV).
Using bioluminescent protein to map tooth decay, Calcivis nets FDA blessing
AbbVie, a research-based global biopharmaceutical company, announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a change to the marketing authorization for Maviret (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT) 3 infection.
NORTH CHICAGO, Ill., Jan. 31, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a change to the marketing authorization for MAVIRET® (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT) 3 infection. MAVIRET is currently indicated as an 8-week, pan-genotypic (GT1-6), once-daily regimen for treatment-naïve HCV patients without cirrhosis, and as an 8-week, once-daily regimen for treatment-naïve GT 1, 2, 4, 5 and 6 HCV patients with compensated cirrhosis.1* If approved by the European Commission (EC), MAVIRET will be the only 8-week treatment option for treatment-naïve chronic HCV patients, without cirrhosis or with compensated cirrhosis, regardless of genotype.*
AbbVie $ABBV has obtained FDA approval to administer its Mavyret hepatitis C pill as a two-month regimen, versus the 12-week course it was originally cleared for — a move that may help expand options for the margin of covered patients who need a shorter regimen.
US FDA granted expanded approval for Mavyret that will allow patients to be treated for the hepatitis C virus in eight weeks.
AbbVie, a research-based global biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has granted approval of Mavyret (glecaprevir/pibrentasvir) to shorten the once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients across all genotypes (GT1-6). In August 2017, Mavyret received regulatory approval in the US as an 8-week, pan-genotypic treatment for treatment-naïve HCV patients without cirrhosis.
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of MAVYRET® (glecaprevir/pibrentasvir) to shorten the once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients across all genotypes (GT1-6). In August 2017, MAVYRET received regulatory approval in the U.S. as an 8-week, pan-genotypic treatment for treatment-naïve HCV patients without cirrhosis.
The U.S. Food and Drug Administration today expanded the approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve). Mavyret is now the first eight-week treatment approved for all treatment-naïve adult and certain pediatric patients with HCV genotypes 1-6 both without cirrhosis and with compensated cirrhosis. Standard treatment length for patients with compensated cirrhosis was previously 12 weeks or more.