Methods of treatment of cholestatic diseases
The present invention relates to the use of compound 1-[4-methylthiophenyl]-3-[3,5-dimethyl-4-carboxydimethylmethyloxyphenyl]prop-2-en-1-one (Elafibranor or GFT505) for treating cholestatic diseases, and more specifically PBC and/or PSC.
1. A method for treating pruritus associated to cholestatic disease in a subject having primary biliary cholangitis (PBC) with pruritus, the method comprising orally administering a composition comprising elafibranor or a pharmaceutically acceptable salt of elafibranor at a dose between 70 mg and 130 mg per administration to said subject.
2. The method of claim 1 , wherein the composition comprises elafibranor.
3. The method of claim 1 , wherein said composition is formulated in a form selected from the group consisting of an injectable suspension, a gel, an oil, a pill, a tablet, a suppository, a powder, a gel cap, a capsule, an aerosol, and a galenic form or device assuring a prolonged and/or slow release.
4. The method of claim 1 , wherein clafibranor the composition is administered once a day.
5. The method of claim 1 , wherein the administration dose is of 80 mg or 120 mg per administration.
6. The method of claim 2 , wherein the subject having primary biliary cholangitis (PBC) with pruritus has an inadequate response to ursodeoxycholic acid.
7. The method of claim 1 , the method comprising further administering to the subject in need thereof another anti-cholestatic agent.
8. The method of claim 7 , wherein the other anti-cholestatic agent is ursodeoxycholic acid (UDCA).
9. The method according to claim 1 , the method comprising administering elafibranor at a dose of 80 mg per administration and ursodeoxycholic acid (UDCA), to the subject in need thereof.
10. The method according to claim 1 , the method comprising administering elafibranor at a dose of 80 mg per administration and ursodeoxycholic acid (UDCA), to a subject having primary biliary cholangitis (PBC) with pruritus and an inadequate response to ursodeoxycholic acid.