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AbbVie's Mavyret scores FDA label expansion to shorten treatment duration for hepatitis C patients

Published on 27/09/19 at 12:11pm

The FDA has chosen to expand the existing label for AbbVie’s Mavyret (glecaprevir/pibrentasvir), it has been revealed, to include the treatment of previously untreated patients over the age of 12 who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis.

The approval will see the duration of treatment with the drug shortened from 12 to eight weeks.

The US regulator authorised the therapy on the back on Phase 3b data in which 98% of 336 participants experienced a sustained virologic response after receiving the drug for 12 weeks. During the trial, just one relapse was recorded, with no patients halting treatment due to adverse events.

“While over 100,000 patients have been prescribed Mavyret for chronic HCV in the US, there are still a significant number of patients that need options,” explained Dr Janet Hammond, Vice President, General Medicine and Virology Therapeutic Area at AbbVie. “This approval provides more HCV patients an option to treat their disease in as little as eight weeks.”

Matt Fellows

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