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Albireo to Present at the 2021 Wedbush PacGrow Virtual Healthcare Conference apnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from apnews.com Daily Mail and Mail on Sunday newspapers.
– Commercial launch of Bylvay immediate; available for prescription in the coming days – – Rare Pediatric Disease Priority Review Voucher issued to Albireo by the FDA – – Company to host investor conference call on July 21 at 8:30 a.m. ET – BOSTON, July 20, 2021 (GLOBE NEWSWIRE) Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today announced U.S. Food & Drug Administration (FDA) approval of Bylvay (odevixibat), the first drug approved for the treatment of pruritus in all subtypes of progressive familial intrahepatic cholestasis (PFIC). Bylvay is a potent, non-systemic ileal bile acid transport inhibitor (IBATi), which does not require refrigeration and is easily administered as a once-daily capsule or opened and sprinkled onto soft foods. Albireo is launching Bylvay immediately to accelerate availability for the patients and families impacted by PFIC. ....
– Data being presented show long-term benefits of Bylvay in children with PFIC – – First potential non-invasive treatment option that could transform the . ....
- Bylvay has the potential to become first approved drug to treat all forms of PFIC - - CHMP opinion is based on the PEDFIC Phase 3 studies - - PEDFIC 1 met the bile acid (P=0.003) and pruritus ....