By Connor Hart

AbbVie said the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval of its treatment for acute hepatitis C.

The final European Commission decision is expected to occur during the third quarter, the biopharmaceutical conglomerate said Friday.

If approved, the treatment--called Maviret--would be indicated for both acute and chronic hepatitis C infection in the European Union.

The positive opinion represents an important step toward enabling earlier treatment, said Primal Kaur, senior vice president for global development of immunology, neuroscience, eye care and specialty at AbbVie.

Hepatitis C, or HCV, is a serious blood-borne virus that can progress to chronic liver disease when left untreated, the company said. Moreover, acute HCV infection is frequently asymptomatic and may go undiagnosed until it has progressed to a later stage.

"This milestone aligns with global clinical guidance supporting treatment of suitable people with acute or chronic HCV infection," Kaur said.

"It also has the potential to help address unmet need, reduce the risk of onward transmission, and support global HCV elimination efforts."

The new recommendation applies to adults and children aged 3 years and older. It is supported by data from a late-stage trial, in which Maviret demonstrated a 96% cure rate after 12 weeks of treatment, AbbVie said.

The drug's safety profile was generally consistent with past trials, with the most common adverse effects being fatigue, diarrhea and headache.

AbbVie said it continues to collaborate with global regulatory authorities to support access to the drug, which is currently approved in Canada, Australia, the U.S., Saudi Arabia, New Zealand, Taiwan and Argentina.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

May 22, 2026 08:37 ET (12:37 GMT)

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