Methods of treating multiple sclerosis
AssigneeBiogen MA Inc.
InventorsMark Novas, Rui (Ray) Zhang
Life of this patent
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Abstract
Provided herein are methods of treating multiple sclerosis with a fumarate, wherein the fumarate is a dialkyl fumarate, a monoalkyl fumarate, a combination of a dialkyl fumarate and a monoalkyl fumarate, a prodrug of monoalkyl fumarate, a deuterated form of any of the foregoing, or a pharmaceutically acceptable salt, clathrate, solvate, tautomer, or stereoisomer of any of the foregoing, or a combination of any of the foregoing. The methods provided herein improve the safety of treatment by informing and monitoring patients undergoing treatment regarding progressive multifocal leukoencephalopathy, and/or by monitoring lymphocyte count.
Claims20
1-313. (canceled)
A method of treating multiple sclerosis (“MS”) by:
- (a) administering a pharmaceutical composition comprising a fumarate, wherein said fumarate is dimethyl fumarate (“DMF”), monomethyl fumarate (“MMF”), or a combination of DMF and MMF;
- with the provisos that:
- (i) a fumarate salt is not present in the pharmaceutical composition;
- and
- (ii) no additional fumarate other than the dimethyl fumarate, monomethyl fumarate, or combination thereof, is present in the pharmaceutical composition;
- (b) obtaining complete blood count including lymphocyte counts from the patients:
- (i) after 6 months of repeated administering of the pharmaceutical composition;
- and
- (ii) every 6 to 12 months thereafter;
- (c) for those patients who have a lymphocyte count less than 0.5×109/L (a “low lymphocyte count”):
- (i) interrupting administration of said pharmaceutical composition only if such low lymphocyte count persists for more than six months;
- and
- (ii) continuing administration of said pharmaceutical composition if a later lymphocyte count is not less than 0.5×109/L.
A method of treating multiple sclerosis (“MS”) by administering treatment to patients for which a complete blood count including lymphocyte count has been obtained, which treatment comprises:
- orally administering 240 mg dimethyl fumarate (“DMF”) twice a day, to an MS patient who has been receiving treatment with DMF for at least 6M, wherein the patient:
- (i) has had at least one lymphocyte count below 0.5×109/L;
- and
- (ii) has not had a lymphocyte count below 0.5×109/L that persists for more than 6M.
Dependencies are inferred from the claim text.