FDA Grants Rare Pediatric Disease Designation to A4250; Albireo Eligible to Apply for Priority Review Voucher
Albireo Pharma, Inc. (ALBO)
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Source: GlobeNewswire
BOSTON, June 12, 2018 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation to lead product candidate A4250, an ileal bile acid transporter (IBAT) inhibitor, for the treatment of progressive familial intrahepatic cholestasis (PFIC), a rare and life-threatening liver disease with no approved pharmacologic treatment option. “This designation affirms Albireo’s eligibility to apply for a rare pediatric disease priority review voucher upon submission of a new drug application for A4250 and highlights the serious, life-threatening manifestations of PFIC,” said Ron Cooper, President and Chief Executive Officer of Albireo. “A priority review voucher is a very valuable and important component of the incentives to develop products for rare, life-threatening diseases.” Albireo recently annou
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