Granted Patent
B2
US 12,709,642 · App. 16/038,816 · Granted Aug 18, 2026
Methods for treating nasal polyposis by administering an IL-4R antagonist
Inventors:
Leda Mannent (Paris, FR); Gianluca Pirozzi (Bridgewater, NJ); Allen Radin (Tarrytown, NY); Namita A. Gandhi (Tarrytown, NY); Robert Evans (Tarrytown, NY)
C07K16/2866A61K31/135A61K31/136A61K31/137A61K31/167A61K31/56A61K31/58A61K39/395A61K39/3955A61K45/06A61K2039/505C07K2317/21
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Abstract
The present invention provides methods for treating nasal polyposis. The methods include 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 or antigen binding fragment thereof.
Claims (36)
1 . A method for treating nasal polyposis in a subject in need thereof,
wherein the subject has nasal polyposis that is inadequately controlled by surgery to remove nasal polyps, comprising:
administering to the subject a full antibody that specifically binds an interleukin-4 receptor (IL-4R), wherein the antibody comprises a heavy chain variable region (HCVR) sequence comprising the amino acid sequence of SEQ ID NO: 1 and a light chain variable region (LCVR) sequence comprising the amino acid sequence of SEQ ID NO: 2.
2 . The method of claim 1 , wherein the antibody is dupilumab.
3 . The method of claim 1 , wherein the antibody is administered to the subject subcutaneously.
4 . The method of claim 1 , wherein the antibody is administered at a dose of 0.1 mg to 600 mg.
5 . The method of claim 1 , wherein the antibody is administered at a dose of 100 mg to 400 mg.
6 . The method of claim 1 , wherein the antibody is administered at a dose of 300 mg.
7 . The method of claim 1 , wherein the antibody is administered to the subject subcutaneously at a dose of 300 mg.
8 . The method of claim 1 , wherein a second therapeutic agent is administered to the subject before, after or concurrent with the antibody.
9 . The method of claim 8 , wherein the second therapeutic agent is selected from the group consisting of an IgE inhibitor, an antibiotic agent, and an anti-fungal agent.
10 . The method of claim 8 , wherein the second therapeutic agent comprises an intranasal corticosteroid.
11 . The method of claim 10 , wherein the intranasal corticosteroid is mometasone furoate nasal spray (MFNS).
12 . The method of claim 8 , wherein the second therapeutic agent comprises an inhaled corticosteroid, wherein the inhaled corticosteroid is fluticasone or budesonide.
13 . The method of claim 12 , wherein the second therapeutic agent is part of a combination therapy further comprising a long-acting beta 2 agonist, wherein the long-acting beta 2 agonist is salmeterol or formoterol.
14 . The method of claim 8 , wherein the second therapeutic agent comprises a fluticasone/salmeterol combination therapy.
15 . The method of claim 8 , wherein the second therapeutic agent comprises a budesonide/formoterol combination therapy.
16 . The method of claim 8 , wherein a second therapeutic agent selected from the group consisting of a nasal saline, a topical decongestant, a topical anesthetic, a leukotriene antagonist, and a systemic antihistamine is administered to the subject before, after, or concurrent with the antibody.
17 . A method for treating nasal polyposis in a subject in need thereof,
wherein the subject has nasal polyposis that is inadequately controlled by surgery to remove nasal polyps, comprising:
administering to the subject an initial dose of a full antibody that specifically binds an interleukin-4 receptor (IL-4R), followed by one or more subsequent doses of the antibody, wherein the antibody comprises a heavy chain variable region (HCVR) sequence comprising the amino acid sequence of SEQ ID NO: 1 and a light chain variable region (LCVR) sequence 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 17 , wherein each subsequent dose of the antibody is administered 2 weeks after the immediately preceding dose of the antibody.
20 . The method of claim 17 , wherein each subsequent dose of the antibody is administered 4 weeks after the immediately preceding dose of the antibody.
21 . The method of claim 17 , wherein the initial dose of the antibody and the one or more subsequent doses of the antibody are administered subcutaneously.
22 . The method of claim 17 , wherein the initial dose of the antibody and the one or more subsequent doses of the antibody each comprises 300 mg.
23 . The method of claim 17 , wherein a second therapeutic agent is administered to the subject before, after or concurrent with the initial dose of the antibody or the one or more subsequent doses of the antibody.
24 . The method of claim 23 , wherein the second therapeutic agent is selected from the group consisting of an IgE inhibitor, an antibiotic agent, and an anti-fungal agent.
25 . The method of claim 23 , wherein the second therapeutic agent comprises an intranasal corticosteroid.
26 . The method of claim 25 , wherein the intranasal corticosteroid is mometasone furoate nasal spray (MFNS).
27 . The method of claim 23 , wherein the second therapeutic agent comprises an inhaled corticosteroid, wherein the inhaled corticosteroid is fluticasone or budesonide.
28 . The method of claim 27 , wherein the second therapeutic agent is part of a combination therapy further comprising a long-acting beta 2 agonist, wherein the long-acting beta 2 agonist is salmeterol or formoterol.
29 . The method of claim 23 , wherein the second therapeutic agent comprises a fluticasone/salmeterol combination therapy.
30 . The method of claim 23 , wherein the second therapeutic agent comprises a budesonide/formoterol combination therapy.
31 . The method of claim 23 , wherein a second therapeutic agent selected from the group consisting of a nasal saline, a topical decongestant, a topical anesthetic, a leukotriene antagonist, and a systemic antihistamine is administered to the subject before, after, or concurrent with the antibody.
32 . The method of claim 21 , wherein the antibody is administered using an autoinjector, a prefilled syringe, or a prefilled pen.
Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jul 17, 2026
From: MANNENT, LEDA; PIROZZI, GIANLUCA
To: SANOFI
Reel/Frame 075306/0579 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jul 17, 2026
From: SANOFI
To: SANOFI BIOTECHNOLOGY
Reel/Frame 075306/0693 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Aug 24, 2018
From: RADIN, ALLEN; GANDHI, NAMITA A.; EVANS, ROBERT
To: REGENERON PHARMACEUTICALS, INC.
Reel/Frame 046691/0709 →
Priority Claims (1)
EP 14305670
· May 7, 2014
· regional
Continuity (3)
Provisional Application
61837912
· Jun 21, 2013
Related Publication
20190040146A1
· Feb 7, 2019
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