EMA’s Paediatric Committee Agrees to Albireo’s A4250 Pediatric Investigation Plan
Albireo Pharma, Inc. (ALBO)
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Source: GlobeNewswire
Agreement an essential step for a potential EU marketing authorization application Completion of PIP would provide an additional two years of market exclusivity Planned Phase 3 clinical trial a key component of agreed PIP BOSTON, Sept. 26, 2017 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) has agreed to Albireo's pediatric investigation plan (PIP) for lead product candidate A4250 in patients with progressive familial intrahepatic cholestasis (PFIC). PFIC is a rare and life-threatening genetic liver disease for which there are currently no approved drug therapies. “Because we are developing A4250 to treat a pediatric patient population, we are especially pleased that the PDCO, which is responsible for activities on potential medicines for pediatric populations and support
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