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– 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