Posted by Michael Wonder on 18 Oct 2018
Albireo receives FDA fast track designation for A4250
17 October 2018 - Albireo Pharma today announced the U.S. FDA has granted Fast Track designation to lead product candidate A4250, an ileal bile acid transporter inhibitor, which is being developed for the treatment of progressive familial intra-hepatic cholestasis (PFIC), a rare and life-threatening liver disease with no approved pharmacologic treatment option.
In addition to Fast Track designation, A4250 has received several other special regulatory designations for development in PFIC. The FDA has granted A4250 Orphan Drug Designation and Rare Pediatric Disease designation with eligibility to apply for a Priority Review Voucher. The European Medicines Agency (EMA) has granted A4250 Orphan Drug Designation, as well as access to the PRIority MEdicines (PRIME) program, and its Paediatric Committee has agreed to Albireo's A4250 Pediatric Investigation Plan.
