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Tuesday, July 20, 2021

Albireo gets FDA OK for liver disease med

– Only once-daily drug indicated for the treatment of pruritus in PFIC –

– 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 –

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.

Conference Call
Albireo will host a conference call and webcast tomorrow, July 21, 2021 at 8:30 a.m. ET. To access the live conference call by phone, dial 877-407-0792 (domestic) or 201-689-8263 (international), and provide the access code 13720443. Live audio webcast will be accessible from the Albireo Media & Investors page ir.albireopharma.com/. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events & Presentations section of the Albireo Media & Investors page for three months following the event.

https://finance.yahoo.com/news/albireo-announces-fda-approval-bylvay-200000206.html

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