Albireo Pharma announces the FDA accepted sNDA, issued PDUFA for Bylvay

Albireo Pharma 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 indication for patients with Alagille syndrome, ALGS. With completed submissions for Bylvay in the U.S. and EU for use in patients with ALGS, the Company anticipates approvals in mid-2023. "After completing the regulatory submissions in record time and now with FDA Priority Review acceptance, we are one step closer to bringing Bylvay to market to treat patients with Alagille syndrome, providing hope for this rare disease community that deserves treatment options," said Ron Cooper, President and Chief Executive Officer of Albireo. "With the Phase 3 randomized, placebo-controlled ASSERT data and Orphan Designation, we are planning for approval in Alagille syndrome in mid-2023, expanding access to Bylvay for more of the cholestatic liver community."