Granted Patent
B2
US 12,589,086 · App. 18/017,591 · Granted Mar 31, 2026
Compositions and methods for the treatment of primary biliary cholangitis
Inventors:
Pascal Birman (Paris, FR); Alice Roudot (Lomme, FR); David Magrez (Lambersart, FR); Benoit Noel (Gondecourt, FR)
Assignee:
Genfit
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Abstract
The invention relates to a pharmaceutical composition comprising elafibranor or a pharmaceutically acceptable salt thereof, for use to treat primary biliary cholangitis (PBC) in a subject intolerant to ursodeoxycholic acid (UDCA).
Claims (9)
1 . A method of treating primary biliary cholangitis (PBC) comprising administering to a patient a pharmaceutical composition comprising 2-(2,6-dimethyl-4-{3-[4-(methylsulfanyl)phenyl]-3-oxopropen-1-yl}phenoxy)-2-methylpropanoic acid (elafibranor) or a pharmaceutically acceptable salt thereof, wherein the patient suffers from PBC and is intolerant to treatment with ursodeoxycholic acid (UDCA).
2 . The method according to claim 1 , wherein the patient has a contraindication to be treated by UDCA or is unable to be compliant with the UDCA-medication due to an adverse event or condition.
3 . The method according to claim 2 , wherein the patient having a contraindication to be treated by UDCA is a pregnant woman; a patient with complete biliary obstruction of extrahepatic origin; a patient with widespread intrahepatic obstruction; a patient with calcified cholesterol stones, radiopaque stones or radiolucent bile pigment stones, malfunctioning gallbladder; a patient with acute inflammation of the gallbladder or of the biliary tract; or a patient with frequent biliary colic.
4 . The method according to claim 2 , wherein the adverse event or condition is leucopenia; ulcerates; immune suppression and consequent fever; incoercible or otherwise unexplained diarrhea; pneumonia; pharyngitis; otitis media; bronchopneumonia; bronchitis; oral moniliasis; abscess formations; dysuria or recurrent watery diarrhea; stomach burns; tubulointerstitial nephritis; leukocytoclastic vasculitis; skin rash; thrombocytopenia; recurrent wheezy chest, cough or interstitial lung disease; hepatic complications such as vanishing bile duct syndrome, pruritus, cholangitis, ascites, increasing cholestasis, portal hypertension or liver cell failure; convulsions; nausea; vomiting; sleep disturbance; or diabetes.
5 . The method according to claim 1 , wherein said pharmaceutical composition is a tablet, injectable suspension, gel, oil, pill, suppository, powder, gel cap, capsule, aerosol, or a prolonged or slow release dosage form.
6 . The method according to claim 1 , wherein said pharmaceutical composition is for oral administration once a day.
7 . The method according to claim 1 , wherein elafibranor or a pharmaceutically acceptable salt thereof is administered at a dose varying between 10 mg and 200 mg per administration.
8 . The method according to claim 1 , wherein elafibranor or a pharmaceutically acceptable salt thereof is administered at a dose varying between 80 mg and 120 mg per administration.
9 . The method according to claim 8 , wherein said pharmaceutical composition is a tablet comprising 80 mg of elafibranor.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jul 10, 2023
From: BIRMAN, PASCAL; ROUDOT, ALICE; MAGREZ, DAVID; NOEL, BENOIT
To: GENFIT
Reel/Frame 064195/0267 →
Priority Claims (1)
EP 20305953
· Aug 26, 2020
· regional
Continuity (1)
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