Posted by Michael Wonder on 09 Dec 2020
Albireo submits for U.S. FDA and EMA product approval of once daily odevixibat for PFIC
8 December 2020 - Data on PFIC types 1, 2, 3 submitted to support use across a wide range of patients.
Albireo Pharma today announced it has submitted a new drug application to the U.S. FDA and a marketing authorisation application to the EMA seeking approval of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC).
The EMA has validated the odevixibat marketing authorisation applicatipn on the accelerated assessment timeline, which begins the formal review process.
