Progressive familial intrahepatic cholestasis (PFIC)
Development and Regulatory status
Oct 18: Odevixibat receives Fast Track designation in US for PFIC  Mar 17: According to Albireo pipeline, PII studies have started .
Mar 17: Has orphan drug status in the US & EU . 10/03/2017 12:17:57
Nov 16: Granted PRIME (PRIority MEdicines) status in the EU for treatment of PFIC. Albireo plans to initiate a pivotal clinical trial in PFIC in the US and Europe, and anticipates meeting with the US FDA regarding the planned trial in Q1 17 .
Trial or other data
Sep 18: Phase III PEDFIC 2 trial (NCT03659916) initiated in the EU and US to evaluate long term safety and efficacy of odevixibat in children with PFIC types 1 and 2. 
May 18: First patient enrolled in the Pivotal phase III PEDFIC-1 trial (NCT03566238) of odevixibat in patients with PFIC. The randomised, double-blind, placebo-controlled trial will enrol approximately 60 patients in the EU and US 
Feb 15: Albireo announces results from a PI trial that evaluated the safety, pharmacokinetics and pharmacodynamics of A4250 in healthy volunteers . ·