Mirum Pharmaceuticals Submits European Marketing Authorization Application for Liver Disease Treatment

By Chris Wack

Mirum Pharmaceuticals Inc. said it has submitted a marketing authorization application for the treatment of cholestatic liver disease in patients with Alagille syndrome to the European Medicines Agency.

In conjunction with the ALGS submission, Mirum's marketing authorization application for progressive familial intrahepatic cholestasis type 2 was withdrawn with plans to re-submit after availability of results from its Phase 3 study in a broader set of PFIC sub-types and with higher doses of maralixibat.

In the U.S., the Food and Drug Administration has accepted Mirum's new drug application for maralixibat for the treatment of cholestatic pruritus in patients with ALGS and the company is preparing for a potential launch following the PDUFA date of Sept. 29, if approved by the FDA.

Mirum shares were up 5% to $19 in premarket trading.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

09-13-21 0737ET