Albireo Receives UK MHRA Approval of Bylvay® (odevixibat)
Albireo Pharma, Inc. (ALBO)
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Source: GlobeNewswire
– Bylvay now approved in U.S., EU and UK as first drug treatment for patients with PFIC – – Only once-daily drug indicated to treat all forms of PFIC – – MHRA decision based on data from the largest Phase 3 PFIC trial to date – BOSTON, Sept. 08, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare pediatric liver disease company developing novel bile acid modulators, today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Bylvay (odevixibat) for the treatment of all types of progressive familial intrahepatic cholestasis (PFIC). Bylvay is a potent, non-systemic ileal bile acid transport inhibitor (IBATi), administered as a once-daily capsule or opened and sprinkled onto soft foods and which does not require refrigeration.The MHRA authorization follows the European Commission (EC) authorization of Bylvay in July 2021. “The approval of Bylvay gives parents tremendous hope as the first drug treatm
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