Claims for Patent: 10,137,193

Summary for Patent: 10,137,193

Title:	Methods for treating or preventing asthma by administering an IL-4R antagonist
Abstract:	The invention provides methods for treating or preventing asthma and associated conditions in a patient. The methods featured in the invention comprise administering to a subject in need thereof a therapeutic composition comprising an interleukin-4 receptor (IL-4R) antagonist, such as an anti-IL-4R antibody.
Inventor(s):	Pirozzi; Gianluca (Berkeley Heights, NJ), Skobieranda; Franck (Flourtown, PA), Li; Yongtao (Springfield, NJ), Graham; Neil (Croton-on-Hudson, NY), Weinstein; Steven P. (Hartsdale, NY)
Assignee:	Sanofi Biotechnology (FR) Regeneron Pharmaceuticals, Inc. (Tarrytown, NY)
Application Number:	14/627,728
Patent Claims:	1. A method for treating persistent asthma in a subject in need thereof comprising administering to the subject a combination therapy comprising: i) one or more maintenance doses of an inhaled corticosteroid (ICS), ii) one or more maintenance doses of a long-acting beta.sub.2-adrenergic agonist (LABA), iii) a loading dose of about 600 mg of an antibody or an antigen-binding fragment thereof that specifically binds to interleukin-4 receptor (IL-4R) comprising three Heavy chain Complementarity Determining Region (HCDR) sequences comprising SEQ ID NOs: 3, 4, and 5, and three Light chain Complementarity Determining Region (LCDR) sequences comprising SEQ ID NOs: 6, 7, and 8, and iv) one or more maintenance doses of about 300 mg of the antibody or the antigen-binding fragment thereof, wherein the ICS and LABA are administered for the duration of administration of the antibody or the antigen-binding fragment thereof. 2. The method of claim 1, wherein the antibody or antigen-binding fragment thereof that specifically binds to IL-4R comprises a Heavy Chain Variable Region (HCVR) comprising the amino acid sequence of SEQ ID NO: 1 and a Light Chain Variable Region (LCVR) comprising the amino acid sequence of SEQ ID NO: 2. 3. The method of claim 2, wherein the antibody is dupilumab. 4. The method of claim 1, wherein the one or more maintenance doses are administered every other week (q2w). 5. The method of claim 4, wherein the maintenance doses of the antibody or antigen-binding fragment thereof are administered for at least 24 weeks. 6. The method of claim 1, wherein the one or more maintenance doses are administered every fourth week (q4w). 7. The method of claim 6, wherein the maintenance doses of the antibody or antigen-binding fragment thereof are administered for at least 24 weeks. 8. The method of claim 1, wherein the antibody or antigen-binding fragment thereof is administered to the subject systemically, subcutaneously, intravenously, or intranasally. 9. The method of claim 1, wherein the subject has a blood eosinophil count selected from the group consisting of: greater than or equal to 300 cells/.mu.L, 200 to 299 cells/.mu.L; and less than 200 cells/.mu.L. 10. The method of claim 1, wherein the ICS is selected from the group consisting of: mometasone furoate, budesonide, and fluticasone propionate. 11. The method of claim 1, wherein the LABA is selected from the group consisting of: formoterol and salmeterol. 12. The method of claim 1, wherein the subject is 12 years of age and above. 13. A method for increasing Forced Expiratory Volume in 1 second (FEV1) in liters to treat persistent asthma in a subject in need thereof comprising administering to the subject a combination therapy comprising: i) one or more maintenance doses of an ICS, ii) one or more maintenance doses of a LABA, iii) a loading dose of about 600 mg of an antibody or an antigen-binding fragment thereof that specifically binds to IL-4R comprising three HCDR sequences comprising SEQ ID NOs: 3, 4, and 5, and three LCDR sequences comprising SEQ ID NOs: 6, 7, and 8, and iv) one or more maintenance doses of about 300 mg of the antibody or the antigen-binding fragment thereof, wherein the ICS and LABA are administered for the duration of administration of the antibody or the antigen-binding fragment thereof. 14. A method for improving one or more persistent asthma-associated parameter(s) in a subject in need thereof comprising administering to the subject a combination therapy comprising: i) one or more maintenance doses of an ICS, ii) one or more maintenance doses of a LABA, iii) a loading dose of about 600 mg of an antibody or an antigen-binding fragment thereof that specifically binds to IL-4R comprising three HCDR sequences comprising SEQ ID NOs: 3, 4, and 5, and three LCDR sequences comprising SEQ ID NOs: 6, 7, and 8, and iv) one or more maintenance doses of about 300 mg of the antibody or the antigen-binding fragment thereof, wherein the ICS and LABA are administered for the duration of administration of the antibody or the antigen-binding fragment thereof. 15. A method for reducing an asthma patient's dependence on ICS and/or LABA for the treatment of one or more exacerbations of persistent asthma comprising: (a) selecting a patient who has moderate-to-severe asthma that is uncontrolled with a background asthma therapy comprising an ICS, a LABA, or a combination thereof; and (b) administering to the patient a combination therapy comprising: i) one or more maintenance doses of an ICS, ii) one or more maintenance doses of a LABA, iii) a loading dose of about 600 mg of an antibody or an antigen-binding fragment thereof that specifically binds to IL-4R comprising three HCDR sequences comprising SEQ ID NOs: 3, 4, and 5, and three LCDR sequences comprising SEQ ID NOs: 6, 7, and 8, and iv) one or more maintenance doses of about 300 mg of the antibody or the antigen-binding fragment thereof, wherein the ICS and LABA are administered for the duration of administration of the antibody or the antigen-binding fragment thereof. 16. A method for treating persistent asthma in a subject in need thereof comprising administering to the subject a combination therapy comprising: i) one or more maintenance doses of an inhaled corticosteroid (ICS), ii) one or more maintenance doses of a long-acting beta.sub.2-adrenergic agonist (LABA), iii) a loading dose of about 400 mg of an antibody or an antigen-binding fragment thereof that specifically binds to interleukin-4 receptor (IL-4R) comprising three Heavy chain Complementarity Determining Region (HCDR) sequences comprising SEQ ID NOs: 3, 4, and 5, and three Light chain Complementarity Determining Region (LCDR) sequences comprising SEQ ID NOs: 6, 7, and 8, and iv) one or more maintenance doses of about 200 mg of the antibody or the antigen-binding fragment thereof, wherein the ICS and LABA are administered for the duration of administration of the antibody or the antigen-binding fragment thereof. 17. The method of claim 16, wherein the antibody or antigen-binding fragment thereof that specifically binds to IL-4R comprises a Heavy Chain Variable Region (HCVR) comprising the amino acid sequence of SEQ ID NO: 1 and a Light Chain Variable Region (LCVR) comprising the amino acid sequence of SEQ ID NO: 2. 18. The method of claim 17, wherein the antibody is dupilumab. 19. The method of claim 16, wherein the one or more maintenance doses are administered every other week (q2w). 20. The method of claim 19, wherein the maintenance doses of the antibody or antigen-binding fragment thereof are administered for at least 24 weeks. 21. The method of claim 16, wherein the one or more maintenance doses are administered every fourth week (q4w). 22. The method of claim 21, wherein the maintenance doses of the antibody or antigen-binding fragment thereof are administered for at least 24 weeks. 23. The method of claim 16, wherein the antibody or antigen-binding fragment thereof is administered to the subject systemically, subcutaneously, intravenously, or intranasally. 24. The method of claim 16, wherein the subject has a blood eosinophil count selected from the group consisting of: greater than or equal to 300 cells/.mu.L, 200 to 299 cells/.mu.L; and less than 200 cells/.mu.L. 25. The method of claim 16, wherein the ICS is selected from the group consisting of: mometasone furoate, budesonide, and fluticasone propionate. 26. The method of claim 16, wherein the LABA is selected from the group consisting of: formoterol and salmeterol. 27. The method of claim 16, wherein the subject is 12 years of age and above. 28. A method for increasing Forced Expiratory Volume in 1 second (FEV1) in liters to treat persistent asthma in a subject in need thereof comprising administering to the subject a combination therapy comprising: i) one or more maintenance doses of an ICS, ii) one or more maintenance doses of a LABA, iii) a loading dose of about 400 mg of an antibody or an antigen-binding fragment thereof that specifically binds to IL-4R comprising three HCDR sequences comprising SEQ ID NOs: 3, 4, and 5, and three LCDR sequences comprising SEQ ID NOs: 6, 7, and 8, and iv) one or more maintenance doses of about 200 mg of the antibody or the antigen-binding fragment thereof, wherein the ICS and LABA are administered for the duration of administration of the antibody or the antigen-binding fragment thereof. 29. A method for improving one or more persistent asthma-associated parameter(s) in a subject in need thereof comprising administering to the subject a combination therapy comprising: i) one or more maintenance doses of an ICS, ii) one or more maintenance doses of a LABA, iii) a loading dose of about 400 mg of an antibody or an antigen-binding fragment thereof that specifically binds to IL-4R comprising three HCDR sequences comprising SEQ ID NOs: 3, 4, and 5, and three LCDR sequences comprising SEQ ID NOs: 6, 7, and 8, and iv) one or more maintenance doses of about 200 mg of the antibody or the antigen-binding fragment thereof, wherein the ICS and LABA are administered for the duration of administration of the antibody or the antigen-binding fragment thereof. 30. A method for reducing an asthma patient's dependence on ICS and/or LABA for the treatment of one or more exacerbations of persistent asthma comprising: (a) selecting a patient who has moderate-to-severe asthma that is uncontrolled with a background asthma therapy comprising an ICS, a LABA, or a combination thereof; and (b) administering to the patient a combination therapy comprising: i) one or more maintenance doses of an ICS, ii) one or more maintenance doses of a LABA, iii) a loading dose of about 400 mg of an antibody or an antigen-binding fragment thereof that specifically binds to IL-4R comprising three HCDR sequences comprising SEQ ID NOs: 3, 4, and 5, and three LCDR sequences comprising SEQ ID NOs: 6, 7, and 8, and iv) one or more maintenance doses of about 200 mg of the antibody or the antigen-binding fragment thereof, wherein the ICS and LABA are administered for the duration of administration of the antibody or the antigen-binding fragment thereof.

Details for Patent 10,137,193

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	March 28, 2017		2034-09-15
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	October 19, 2018		2034-09-15
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	June 18, 2020		2034-09-15