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Bylvay Approved for Progressive Familial Intrahepatic Cholestasis

Bylvay Approved for Progressive Familial Intrahepatic Cholestasis
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The Food and Drug Administration (FDA) has approved Bylvayâ¢ (odevixibat) for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC).
Bylvay, an oral, potent, reversible inhibitor of the ileal bile acid transporter (IBAT), works by decreasing the reabsorption of bile acids (primarily the salt forms) from the terminal ileum. The complete mechanism by which odevixibat improves pruritus in PFIC patients is unknown, but the Company believes that inhibition of the IBAT may be involved. Bylvay may not be effective in PFIC type 2 patients with ABCB11 variants resulting in nonfunctional or complete absence of bile salt export pump protein. ....

City Of , United Kingdom , Richard Thompson , Drug Administration , Molecular Hepatology , College London , நகரம் ஆஃப் , ஒன்றுபட்டது கிஂக்டம் , ரிச்சர்ட் தாம்சன் , மூலக்கூறு ஹெபடாலஜி , கல்லூரி லண்டன் ,

MULTIMEDIA UPDATE - Albireo Announces FDA Approval of

– 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. ....

United States , Vastra Gotalands Lan , City Of , United Kingdom , Colleen Alabiso , Richard Thompson , Hans Vitzthum , Ron Cooper , Lisa Rivero , Emily Ventura , Albireo Pharma Inc , Lifesci Advisors , Children Liver Disease Foundation , European Commission , Resource Network , Exchange Commission , Us Food Drug Administration , Rare Pediatric Disease Priority Review Voucher , Drug Administration , Molecular Hepatology , College London , Travere Therapeutics , Albireo Assist , Care Coordinators , Albireo Media , Orphan Designations ,

Albireo Pharma, Inc.: Albireo Receives Positive CHMP Opinion for Bylvay (odevixibat) for Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC)

- 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 ....

United States , City Of , United Kingdom , Colleen Alabiso , Richard Thompson , Hans Vitzthum , Ron Cooper , Lisa Rivero , Albireo Pharma Inc , Lifesci Advisors , European Commission , Pediatric Committee , Resource Network , United States Or European Union , Exchange Commission , Committee For Medicinal Products Human , European Union , European Medicines Agency , Committee For Medicinal Products Human Use , Access Program , Medicinal Products , Human Use , Chief Executive Officer , Molecular Hepatology , College London , Priority Review ,