Albireo Presents Data on Greater Efficacy in PFIC with Earlier Bylvay Treatment at NASPGHAN

– New data presented at the North American Society for Pediatric Gastroenterology, Hepatology & Nutrition meeting (NASPGHAN)

– Earlier treatment with Bylvay (odevixibat) provided greater efficacy in children with PFIC

– Direct link between level of pruritus relief, liver function, and sleep-related outcomes

– Bylvay improved bile acids, sleep, growth, and quality of life even in patients with low pruritus

BOSTON, Oct. 13, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced the presentation of new data at the NASPGHAN Annual Meeting being held in Orlando, Florida from October 12-15, 2022. A new analysis of pooled data from the landmark Phase 3 PEDFIC 1 and PEDFIC 2 trials demonstrates that Bylvay (odevixibat) reduces serum bile acids and pruritus in children with progressive familial intrahepatic cholestasis (PFIC) who have varying levels of baseline hepatic impairment. Importantly, the analysis shows that significantly more patients with mild hepatic impairment at baseline had a serum bile acid response, suggesting children may benefit from earlier treatment with Bylvay.

Additional data analyses presented at the meeting show that Bylvay reduced pruritus in patients regardless of their baseline pruritus scores. Further, pruritus reductions were associated with improvements in serum bile acids, hepatic parameters, growth, and disease aspects related to sleep, with greater reductions in pruritus associated, in general, with greater improvements across these additional measures.

“These new data provide important evidence that treating children with Bylvay earlier in their disease course could result in greater efficacy,” said Jan Mattsson, Ph.D., Chief Scientific Officer and Head of R&D at Albireo. “Furthermore, the data we are presenting reinforce the medicine’s efficacy in patients with mild pruritus, suggesting patients’ benefit from beginning treatment at the first sign of itching.”

“If a physician is trying to determine when to start treatment with Bylvay, this new data suggest the earlier the better,” said Dr. Lorenzo D’Antiga, Department of Paediatric Hepatology, Gastroenterology, and Transplantation, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo. “We should consider treating patients at an early stage of the disease to preserve their native liver and provide relief from the incessant itching associated with the condition. When we see babies stop scratching and sleeping better, we see quality of life improvements for them and their parents.”