Claims for Patent: 10,555,993

Summary for Patent: 10,555,993

Title:	Dimethyl fumarate and vaccination regimens
Abstract:	Provided herein is a method of treating or preventing a disease or disorder (e.g., MS) in a subject in need thereof, comprising (a) administering to the subject a first dose of a pharmaceutical composition comprising a fumarate agent (e.g., DMF) for a first dosing period; (b) administering a vaccine; and (c) administering to the subject a second dose of the pharmaceutical composition for a second dosing period.
Inventor(s):	Viglietta; Vissia (Boston, MA)
Assignee:	Biogen MA Inc. (Cambridge, MA)
Application Number:	16/391,583
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,555,993
Patent Claims:	1. A method of treating multiple sclerosis in a human subject in need thereof, said method comprising: (a) administering to the subject a first dose of a pharmaceutical composition for a first dosing period, wherein the pharmaceutical composition comprises a fumarate agent selected from the group consisting of monomethyl fumarate, a pharmaceutically acceptable salt of monomethyl fumarate, dimethyl fumarate, and a combination thereof; (b) administering a vaccine to the subject, wherein the subject receives the vaccine during the first dosing period; and (c) administering to the subject a second dose of the pharmaceutical composition for a second dosing period, wherein: (i) the second dosing period is after the first dosing period, and (ii) the second dosing period is initiated within one day of the end of the first dosing period; wherein the second dose is the same as the first dose, and the first dose and the second dose are administered daily; wherein the multiple sclerosis is a relapsing form of multiple sclerosis; wherein the first dose is a therapeutically effective amount of monomethyl fumarate, a pharmaceutically acceptable salt of monomethyl fumarate, dimethyl fumarate, or a combination thereof; and wherein the vaccine induces (a) a T cell-dependent anamnestic humoral immune response, (b) a T cell-dependent neoantigen immune response, or (c) a T cell-independent immune response. 2. The method of claim 1, wherein the fumarate agent is dimethyl fumarate. 3. The method of claim 2, wherein the first dose is a daily amount of about 480 mg dimethyl fumarate. 4. The method of claim 1, further comprising administering a titration dose of the fumarate agent prior to the first dosing period. 5. The method of claim 4, wherein the fumarate agent is dimethyl fumarate and the titration dose is a daily amount of about 240 mg dimethyl fumarate. 6. The method of claim 1, wherein the pharmaceutical composition is in the form of a capsule or tablet. 7. The method of claim 2, wherein the dimethyl fumarate is in the form of microtablets or micropellets, and wherein the microtablets or micropellets are enterically coated. 8. The method of claim 7 wherein the microtablets or micropellets are contained in a capsule. 9. The method of claim 1, wherein the vaccine induces a T cell-dependent anamnestic humoral immune response. 10. The method of claim 1, wherein the vaccine induces a T cell-dependent neoantigen immune response. 11. The method of claim 1, wherein the vaccine induces a T cell-independent immune response. 12. The method of claim 1, wherein the vaccine is a vaccine selected from the group consisting of tetanus diphtheria toxoids vaccine, keyhole limpet hemocyanin vaccine, pneumovax-23 vaccine, and any combination thereof. 13. The method of claim 12, wherein the vaccine is tetanus diphtheria toxoids vaccine. 14. The method of claim 12, wherein the vaccine is keyhole limpet hemocyanin vaccine. 15. The method of claim 12, wherein the vaccine is pneumovax-23 vaccine. 16. The method of claim 1, wherein the vaccine is meningococcal polysaccharide diphtheria conjugate vaccine quadrivalent. 17. The method of claim 1, wherein the multiple sclerosis is relapsing-remitting multiple sclerosis. 18. The method of claim 1, wherein the multiple sclerosis is secondary progressive multiple sclerosis. 19. The method of claim 3, further comprising administering a titration dose of the fumarate agent prior to the first dosing period. 20. The method of claim 19, wherein the titration dose is a daily amount of about 240 mg dimethyl fumarate. 21. The method of claim 1, wherein the fumarate agent is monomethyl fumarate. 22. The method of claim 1, wherein the fumarate agent is a pharmaceutically acceptable salt of monomethyl fumarate.