FDA Expands AbbVie's Mavyret Label To Include Pediatric Patients With Hepatitis C Infection

The U.S. Food and Drug Administration (FDA) approved a label expansion for AbbVie Inc’s (NYSE:ABBV) Mavyret (glecaprevir/pibrentasvir), an oral pangenotypic direct-acting antiviral (DAA) therapy.

It is now approved for adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis.

Glecaprevir, one of the two DAAs in Mavyret, was Discovered by Enanta Pharmaceuticals, Inc (NASDAQ:ENTA) and developed and commercialized by AbbVie.

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With this approval, Mavyret is the first and only DAA therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate.

HCV is a highly infectious blood-borne disease affecting the liver.

The United States is expected to incur around $120 billion in total medical costs over the next 10 years through 2035 linked to chronic liver disease and other related conditions caused by untreated HCV.

Data from the Phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of Mavyret eight-week treatment in adults with acute HCV infection supported the label expansion.

The study results showed Mavyret to be a highly efficacious treatment for people with acute HCV.

The majority of the adverse events reported were mild or moderate in severity. Fatigue, asthenia, headache, and diarrhea were the most common adverse events.

In 2017, the FDA approved Mavyret to treat adults with chronic (lasting a long time) hepatitis C virus (hep C) genotypes 1, 2, 3, 4, 5, or 6 infections without cirrhosis or with compensated cirrhosis.

In 2019, the FDA approved Mavyret 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).

Price Action: ABBV stock is trading higher by 1.54% to $192.43 at last check Wednesday.

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