Claims for Patent: 11,951,097

Summary for Patent: 11,951,097

Title:	Methods of treating multiple sclerosis
Abstract:	The disclosure relates to methods of treating multiple sclerosis. Also provided are pharmaceutical products containing ponesimod, instructions for use of ponesimod, methods for selling a drug product containing ponesimod, and methods for reducing clinical management events before or during treatment of multiple sclerosis.
Inventor(s):	Allitia DiBernardo, Tatiana Sidorenko, Michel BURCKLEN, Sivi Ouwerkerk-Mahadevan, Andrea VACLAVKOVA, Brian Patrick Hennessy, Hilke KRACKER
Assignee:	Vanda Pharmaceuticals Inc
Application Number:	US17/962,968
Patent Claims:	1. A method for reducing clinical management events before or during treatment of multiple sclerosis in a patient in need thereof, comprising administering ponesimod in an amount and manner that is described in a drug product label for an approved drug product. 2. The method of claim 1, wherein about 20 mg of ponesimod is administered orally once daily. 3. The method of claim 1, wherein the treatment comprises an up-titration step at initiation of the method or upon re-initiation of the method after a discontinuation, comprising administering orally once daily 2 mg of ponesimod on days 1 and 2; 3 mg of ponesimod on days 3 and 4; 4 mg of ponesimod on days 5 and 6; 5 mg of ponesimod on day 7; 6 mg of ponesimod on day 8; 7 mg of ponesimod on day 9; 8 mg of ponesimod on day 10; and 9 mg of ponesimod on day 11; 10 mg of ponesimod on days 12, 13, and 14, followed by administering 20 mg of ponesimod once daily thereafter. 4. The method of claim 1, wherein the multiple sclerosis is relapsing multiple sclerosis. 5. The method of claim 4, wherein the relapsing multiple sclerosis comprises relapsing-remitting disease, clinically isolated syndrome, or active secondary progressive disease. 6. The method of claim 1, wherein the clinical management event comprises first-dose monitoring, genotyping, an eye exam, drug-drug interactions (DDI), or a liver function test, or combinations thereof. 7. The method of claim 6, wherein the reduction is relative to a patient population at substantially the same level of disease progression receiving a standard of care treatment comprising an S1P receptor modulator other than ponesimod. 8. The method of claim 7, wherein the standard of care treatment comprises fingolimod, siponimod, or ozanimod. 9. A method for concomitant treatment with a beta-blocker and ponesimod in a patient in need thereof, wherein the patient is being treated with the beta-blocker and ponesimod treatment is to be initiated, and wherein the patient has a resting heart rate of greater than 55 beats per minute during treatment with the beta-block and prior to initiation of ponesimod, comprising administering ponesimod without interruption to the beta-blocker treatment. 10. The method of claim 9, wherein 20 mg of the ponesimod is administered orally once daily. 11. The method of claim 9, wherein the ponesimod administration comprises an up-titration comprising administering orally once daily 2 mg of ponesimod on days 1 and 2; 3 mg of ponesimod on days 3 and 4; 4 mg of ponesimod on days 5 and 6; 5 mg of ponesimod on day 7; 6 mg of ponesimod on day 8; 7 mg of ponesimod on day 9; 8 mg of ponesimod on day 10; 9 mg of ponesimod on day 11; and 10 mg of ponesimod on days 12, 13, and 14, followed by administering 20 mg of ponesimod once daily thereafter. 12. The method of claim 9, wherein the beta-blocker comprises propranol. 13. The method of claim 12, wherein 80 mg of the propranol is administered orally once daily. 14. The method of claim 9, wherein the patient is in need of treatment for relapsing forms of multiple sclerosis. 15. The method of claim 14, wherein the relapsing forms of multiple sclerosis comprise relapsing-remitting disease, clinically isolated syndrome, or active secondary progressive disease. 16. A method for concomitant treatment with a beta-blocker and ponesimod for a patient in need thereof, wherein the patient is being treated with the beta-blocker and ponesimod treatment is to be initiated, and wherein the patient has a resting heart rate of less than or equal to 55 beats per minute during treatment with the beta-block and prior to initiation of ponesimod, comprising interrupting the beta-blocker treatment until the patient's heart rate is greater than 55 beats per minute and initiating ponesimod treatment in a titration regimen comprising administering orally once daily 2 mg of ponesimod on days 1 and 2; 3 mg of ponesimod on days 3 and 4; 4 mg of ponesimod on days 5 and 6; 5 mg of ponesimod on day 7; 6 mg of ponesimod on day 8; 7 mg of ponesimod on day 9; 8 mg of ponesimod on day 10; 9 mg of ponesimod on day 11; and 10 mg of ponesimod on days 12, 13, and 14, followed by administering a 20 mg maintenance dose of ponesimod once daily thereafter, and reinitiating the beta-blocker after ponesimod has been up-titrated to the maintenance dosage. 17. The method of claim 16, wherein the beta-blocker comprises propranol. 18. The method of claim 17, wherein 80 mg of the propranol is administered orally once daily. 19. The method of claim 16, wherein the patient is in need of treatment for relapsing forms of multiple sclerosis. 20. The method of claim 19, wherein the relapsing forms of multiple sclerosis comprise relapsing-remitting disease, clinically isolated syndrome, or active secondary progressive disease. 21. A method of reinitiating treatment with ponesimod following a missed dose in a patient in need thereof, wherein the patient is being treated with an oral, once daily 20 mg maintenance dose and fewer than four consecutive maintenance doses have been missed, comprising resuming treatment with the maintenance dose. 22. The method of claim 21, wherein the patient is in need of treatment for relapsing forms of multiple sclerosis. 23. The method of claim 22, wherein the relapsing forms of multiple sclerosis comprise relapsing-remitting disease, clinically isolated syndrome, or active secondary progressive disease. 24. A method of reinitiating treatment with ponesimod following a missed dose for a patient in need thereof, wherein the patient is being treated with titration doses comprising administering orally once daily 2 mg of ponesimod on days 1 and 2; 3 mg of ponesimod on days 3 and 4; 4 mg of ponesimod on days 5 and 6; 5 mg of ponesimod on day 7; 6 mg of ponesimod on day 8; 7 mg of ponesimod on day 9; 8 mg of ponesimod on day 10; 9 mg of ponesimod on day 11; and 10 mg of ponesimod on days 12, 13, and 14, followed by administering 20 mg of ponesimod once daily, and fewer than four consecutive titration doses have been missed, comprising resuming treatment with the first missed titration dose and resuming the titration at that dose and titration day. 25. The method of claim 24, wherein the patient is in need of treatment for relapsing forms of multiple sclerosis. 26. The method of claim 25, wherein the relapsing forms of multiple sclerosis comprise relapsing-remitting disease, clinically isolated syndrome, or active secondary progressive disease. 27. A method of reinitiating ponesimod following a missed dose for a patient in need thereof, wherein the patient is being treated with an oral, once daily 20 mg maintenance dose or a 14-day titration regimen comprising administering orally once daily titration doses of 2 mg of ponesimod on days 1 and 2; 3 mg of ponesimod on days 3 and 4; 4 mg of ponesimod on days 5 and 6; 5 mg of ponesimod on day 7; 6 mg of ponesimod on day 8; 7 mg of ponesimod on day 9; 8 mg of ponesimod on day 10; 9 mg of ponesimod on day 11; and 10 mg of ponesimod on days 12, 13, and 14, and four or more consecutive maintenance doses or titration doses have been missed, comprising reinitiating ponesimod with the 14-day titration regimen. 28. The method of claim 27, wherein the patient is in need of treatment for relapsing forms of multiple sclerosis. 29. The method of claim 28, wherein the relapsing forms of multiple sclerosis comprise relapsing-remitting disease, clinically isolated syndrome, or active secondary progressive disease.