Albireo Gets FDA Priority Review of Bylvay in Alagille Syndrome

By Colin Kellaher

Albireo Pharma Inc. on Tuesday said the U.S. Food and Drug Administration granted priority review to its application seeking expanded approval of its Bylvay drug for patients with the rare liver disease Alagille syndrome.

The Boston biopharmaceutical company said FDA approval would more than double the market opportunity for Bylvay, which the agency cleared in 2021 for patients with progressive familial intrahepatic cholestasis.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.

Albireo, which in January agreed to be acquired by France's Ipsen for an initial $952 million, said the agency set a target action date of June 15 for the Alagille application.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

02-14-23 0905ET