Posted by Michael Wonder on 20 Dec 2022
Albireo submits Bylvay Alagille syndrome regulatory filings to FDA and EMA
19 December 2022 - Gold standard Phase 3 ASSERT study supports supplementary filings in the US and EU.
Albireo Pharma today announced the submission of a supplemental new drug application to the US FDA and a variation application to the EMA seeking approval for a second Bylvay indication for use in patients with Alagille syndrome in the second half of 2023.
