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Rare Liver Disease Drug Contenders Among Latest EU Filings

MAA For Bayer’s Finerenone Also Filed

Executive Summary

Among the 13 new drug marketing applications that the European Medicines Agency has most recently accepted for review are two products that could become the first approved treatments for children with progressive familial intrahepatic cholestasis, a life-threatening disorder.

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Orphan Drugs Dominate EU Fast-Track Request Decisions In July

The European Medicines Agency decided this month whether to grant fast-track review for planned marketing authorization applications for three potential new orphan treatments.

EU Decision Time For Albireo’s Rare Liver Disease Drug

Odevixibat, which could become the first drug approved for treating progressive familial intrahepatic cholestasis in children, is up for an opinion from the European Medicines Agency.

Plenty Of Action On EU Accelerated Assessment Front

A number of companies have sought to convince the European Medicine Agency that their drug merits a fast-track regulatory review.

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