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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With $120m in Series A funding, the new company headed by former Lumena execs will advance maralixibat into Phase III in Alagille syndrome and progressive familial intrahepatic cholestasis. Shire acquired Lumena for $260m in 2014, but lost interest in the drug.
Shire's Phase II IMAGO trial of SHP625 in 20 pediatric patients with Alagille syndrome (ALGS) has failed to meet its primary or secondary endpoints.
The company said a planned 9 June advisory committee to review the NDA for obeticholic acid in NASH has been postponed a second time, which means OCA likely will not be approved by 26 June.