Tags : glecaprevir

Regulatory

AbbVie’s Mavyret (glecaprevir/pibrentasvir) Receives FDA’s Approval for its Expanded Indication

Shots: The US FDA has granted approval to Mavyret for shortening the treatment duration from 12 to 8wks. in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients across all genotypes (GT1-6) The label expansion is based on P-IIIb EXPEDITION-8 study assessing Mavyret in treatment naïve, GT1-6 chronic HCV patients with compensated cirrhosis for 8wks., resulted […]Read More

Pharma Regulatory

AbbVie’s Maviret (glecaprevir/pibrentasvir) Receives European Commission Approval for Treatment-Naive Patients

Shots: The marketing authorization is based on P-IIIb EXPEDITION-8 study assessing Maviret in 280 treatment-naive chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6) for 8wks. The P-IIIb EXPEDITION-8 study resulted in @8wks. 97.9% GT1, 2, 4, 5 & 6 patients achieved a sustained virologic response 12wks. (SVR12); no case of virologic failures […]Read More

Regulatory

AbbVie’s Mavyret (glecaprevir and pibrentasvir) Receives FDA’s Approval for All

Shots: The approval follows the clinical study results assessing Mavyret (glecaprevir & pibrentasvir) in 47 children aged 12-17 yrs. with genotype 1, 2, 3 or 4 HCV infection without/mild Cirrhosis resulted in no virus detection @12wks. after receiving Mavyret for 8/16wks. The study assessing Mavyret in pediatric patients with cirrhosis/history of a kidney or liver […]Read More