Claims for Patent: 10,004,808

Summary for Patent: 10,004,808

Title:	Methods of treating ulcerative colitis
Abstract:	Methods for inducing clinical remission of ulcerative colitis in a human patient are described comprising administration of an antibody that has binding specificity for human .alpha.4.beta.7 integrin using a safe dosing regimen of these antibody formulations that is easy to follow, and which results in a therapeutically effective amount of the anti-.alpha.4.beta.7 antibody in vivo.
Inventor(s):	Fox; Irving H. (Wellesley, MA), Scholz; Catherine (Woburn, MA)
Assignee:	MILLENNIUM PHARMACEUTICALS, INC. (Cambridge, MA)
Application Number:	15/215,000
Patent Claims:	1. A method for inducing clinical remission in a human patient having moderately to severely active ulcerative colitis, comprising intravenously administering: a first dose of 300 mg of an antibody that has binding specificity for human .alpha.4.beta.7 integrin, a second dose of 300 mg of the antibody two weeks after the first dose, a third dose of 300 mg of the antibody six weeks after the first dose, and then 300 mg of the antibody every eight weeks thereafter, wherein the antibody comprises the heavy chain variable region sequence of amino acids 20 to 140 of SEQ ID NO:2, and the light chain variable region sequence of amino acids 20 to 131 of SEQ ID NO:4, and wherein the human patient had a lack of an adequate response with, lost response to, or was intolerant to a TNF.alpha. antagonist. 2. The method of claim 1, wherein the heavy chain of the antibody comprises amino acids 20 to 470 of SEQ ID NO:2, and the light chain of the antibody comprises amino acids 20 to 238 of SEQ ID NO:4. 3. The method of claim 1, wherein each dose is intravenously administered as an infusion over about 30 minutes. 4. A method for inducing clinical remission in a human patient having moderately to severely active ulcerative colitis, comprising intravenously administering: a first dose of 300 mg of vedolizumab, a second dose of 300 mg of vedolizumab two weeks after the first dose, a third dose of 300 mg of vedolizumab six weeks after the first dose, and then 300 mg of vedolizumab every eight weeks thereafter, wherein the human patient had a lack of an adequate response with, lost response to, or was intolerant to a TNF.alpha. antagonist.

Details for Patent 10,004,808

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476	05/20/2014		2031-05-02