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FDA Expands AbbVie's Mavyret Label To Include Acute Hepatitis C Treatment (CORRECTED) - Enanta Pharma (NASDAQ:ENTA), AbbVie (NYSE:ABBV)
- On June 11, 2025, the FDA approved a label expansion for AbbVie's MAVYRET to treat acute hepatitis C virus infection in adults and children aged three and older.
- This approval followed data from a multicenter Phase 3 study that demonstrated MAVYRET’s eight-week oral regimen effectively treats acute HCV with a high cure rate.
- MAVYRET enables prompt therapy initiation at diagnosis, aligns with international treatment recommendations, and helps stop the advancement of hepatitis C to long-term illness and serious liver conditions such as cirrhosis and cancer.
- AbbVie announced that MAVYRET’s eight-week treatment achieves a 96% cure rate, and John Ward emphasized that the toll—physically, emotionally, and financially—imposed by hepatitis C, despite it being a treatable disease, remains unacceptably high.
- This expanded label strengthens tools for the public health community to treat more patients and supports efforts toward the global goal of eliminating HCV by 2030.
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MedPage Today
Anti-Aging, Acupuncture and Health NewsMavyretz Approved for Acute Hepatitis C; ALD Deaths Double; Entyvio in Pregnancy
(MedPage Today) -- The FDA expanded the approval of the direct-acting antiviral (DAA) glecaprevir/pibrentasvir (Mavyret), making it the first treatment for acute hepatitis C virus, AbbVie announced. Compared with no treatment for chronic hepatitis...
FDA Expands AbbVie's Mavyret Label To Include Acute Hepatitis C Treatment (CORRECTED) - Enanta Pharma (NASDAQ:ENTA), AbbVie (NYSE:ABBV)
Editor's Note: This headline and story have been updated to clarify that the FDA approval was for an expanded indication to treat acute HCV. The U.S. Food and Drug Administration (FDA) approved a label expansion for AbbVie Inc's (NYSE:ABBV) Mavyret (glecaprevir/pibrentasvir) to include treatment of acute hepatitis C virus (HCV) infection in patients without cirrhosis or with compensated cirrhosis. Glecaprevir, one of the two DAAs in Mavyret, was…
PR Newswire
U.S. FDA Approves Expanded Indication for AbbVie's MAVYRET® (Glecaprevir/Pibrentasvir) as First and Only Treatment for People with Acute Hepatitis C Virus
MAVYRET® (glecaprevir/pibrentasvir) is the first and only oral eight-week pangenotypic treatment option approved for people with acute or chronic hepatitis C...
FDA Expands Indication for AbbVie’s Antiviral as First Treatment for People With Acute Hepatitis C
The antiviral, glecaprevir/pibrentasvir (Mavyet), is the first and only oral 8-week pangenotypic treatment approved for people with acute or chronic hepatitis C. The approval supports global clinical guidelines to advance testing and treatment HCV regardless of chronicity, and supports public health goals for disease elimination.
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