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AbbVie’s new hepatitis drug granted EU accelerated assessment status
AbbVie has announced that its new hepatitis C treatment regimen has been validated for accelerated assessment status by the European Medicines Agency.
The company's marketing authorisation application for the pan-genotypic regimen of glecaprevir and pibrentasvir (G/P) has been accepted, meaning it will now be assessed as a therapeutic option for all major chronic hepatitis C virus genotypes.
If approved, G/P may provide a shorter treatment duration for patients with genotypes 1 to 6 without cirrhosis, who make up the majority of hepatitis C patients, as well as offering an additional treatment option to patients with compensated cirrhosis.
G/P is also intended to address the needs of patients with specific treatment challenges, including those with severe chronic kidney disease and those who have failed to respond to treatment with previous direct-acting antiviral therapies.
Eight registrational studies evaluating more than 2,300 patients in 27 countries have demonstrated the benefits of this therapy across all major genotypes and special populations.
Dr Michael Severino, executive vice-president for research and development and chief scientific officer at AbbVie, said: "We believe G/P has the potential to further impact the HCV treatment landscape, shortening the treatment duration to just eight weeks for the majority of people living with chronic HCV without cirrhosis."
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