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Find Clinical Drug Pipeline Developments & Deals by Albireo Pharma
Bylvay (Odevixibat) is theI BAT inhibitor and first drug approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of progressive familial intrahepatic cholestasis (PFIC).
The acquisition enriches Ipsen’s Rare Disease portfolio including Bylvay (odevixibat), a potent, non-systemic ileal bile-acid transport inhibitor (IBATi), for the treatment of pruritus in patients three months of age and older with PFIC.
Albireo’s pipeline includes Bylvay® (odevixibat), a potent, once-daily, oral, non-systemic ileal bile acid transport inhibitor. Bylvay is being investigated in biliary atresia, a severe and potentially fatal pediatric liver disease, in a pivotal Phase III clinical trial.
Bylvay (odevixibat) is used for the treatment of pruritus in patients 3 months of age and older in all types of PFIC. A potent, once-daily, non-systemic ileal bile acid transport inhibitor, Bylvay has minimal systemic exposure and acts locally in the small intestine.
A potent, once-daily, non-systemic ileal bile acid transport inhibitor, Bylvay (odevixibat) has minimal systemic exposure and acts locally in the small intestine. Bylvay can be taken as a capsule for patients that are able to swallow capsules.
Bylvay® (odevixibat) is the first drug approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of progressive familial intrahepatic cholestasis (PFIC).
In primary analysis of Bylvay (odevixibat) study met primary endpoint showing statistically significant reduction in pruritus as measured by PRUCISION Observer-Reported Outcome scratching score, from baseline at month 6 (weeks 21 to 24), compared to placebo arm (p=0.002).
A potent, non-systemic ileal bile acid transport inhibitor, Bylvay (odevixibat) acts locally in the small intestine. Bylvay may not be effective in PFIC type 2 patients with ABCB11 variants resulting in non-functional or complete absence of bile salt export pump protein.
The agreement grants a first lien security interest on Albireo’s worldwide annual consolidated net revenues relating to Bylvay and associated additional collateral, and does not provide for liens on Albireo’s intellectual property.
Bylvay is the first drug approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of progressive familial intrahepatic cholestasis (PFIC).
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