US-based AbbVie’s marketing authorisation application (MAA) for the investigational, pan-genotypic regimen of glecaprevir (ABT-493) / pibrentasvir (ABT-530) (G/P) has been validated by the European Medicines Agency (EMA).
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EMA’s validation confirms that the submission is complete and the agency’s centralised review process will now begin.
Upon approval, G/P will be used for the treatment of all major chronic hepatitis C virus (HCV) genotypes and could be available for marketing in the European Union (EU) in the second half of this year.
G/P is expected to provide shorter treatment duration for genotypes 1-6 (GT1-6) patients without cirrhosis if it is approved.
It is also aimed at addressing the patient needs with specific treatment challenges, including those with severe chronic kidney disease (CKD) and those who are not cured with previous direct-acting anti-viral (DAA) treatment.
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By GlobalDataAbbVie executive vice-president for research and development and chief scientific officer Michael Severino said: "We will work closely with the EMA as we continue our commitment to potentially provide a cure for as many people living with HCV as possible.
"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."
The G/P regimen will be reviewed by the Committee for Medicinal Products for Human Use (CHMP) and the scientific committee of the EMA under accelerated assessment.
AbbVie announced its new drug application submission for G/P on 19 December last year to the US FDA for the treatment of GT1-6 chronic HCV.
The company proposes to submit a new drug application in Japan in the first quarter of this year.
Image: Electron micrographs of hepatitis C virus purified from cell culture. Photo: courtesy of Maria Teresa Catanese, Martina Kopp, Kunihiro Uryu, and Charles Rice.
