Fda grants june 15, 2023 pdufa date to albireo for bylvay® in alagille syndrome

Boston, feb. 14, 2023 (globe newswire) -- albireo pharma, inc. (nasdaq: albo), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced that the u.s. food and drug administration (fda) has accepted the company's supplemental new drug application (snda) and issued a prescription drug user fee act (pdufa) action date of june 15, 2023 for a second bylvay (odevixibat) indication for patients with alagille syndrome (algs). as defined by the fda, the priority review timeline is 6 months and the agency will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. with completed submissions for bylvay in the u.s. and eu for use in patients with algs, the company anticipates approvals in mid-2023.
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