Since acquiring a pair of mid-stage apical sodium-dependent bile acid transporter (ASBT) inhibitors from Shire PLC in 2018, Mirum Pharmaceuticals has been working to build a case for both in pediatric cholestatic liver disease. Now, with long-term extension data, the company hopes to convince the US Food and Drug Administration on filing maralixibat for pruritus related to Alagille syndrome on the strength of Phase IIb data.
Mirum’s Long-Term Alagille Data Support Case For Early Filing
Newly public Mirum hopes to file maralixibat for US approval in pruritus due to Alagille syndrome based on Phase IIb data, including long-term extension data reported at AASLD.
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