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Albireo's liver therapy gets European Commission orphan status

Albireo Pharma Inc.'s A4250, a medicine for a rare and life-threatening liver disease, received orphan drug designation from the European Commission.

A4250 received the designation to treat biliary atresia, a rare disease of the liver and bile ducts that occurs in infants. The disease currently has no approved treatment option.

The European Commission grants orphan status to medicines developed for treating rare life-threatening or chronically disabling diseases. Companies will usually be granted 10 years of market exclusivity for the drug after regulatory approval, plus an additional two years after completing a pediatric investigation plan.

The drug has also received orphan drug designations in the U.S. and EU for the treatment of progressive familial intrahepatic cholestasis, another rare genetic liver condition.

Albireo President and CEO Ron Cooper said the company plans to expand development of the drug into rare cholestatic liver diseases in 2019.