Granted Patent B2

US 12,702,709 · App. 17/534,106 · Granted Aug 11, 2026

Inventors: Leda Mannent (Paris, FR); Gianluca Pirozzi (Bridgewater, NJ); Brian Swanson (Bridgewater, NJ); Allen Radin (New York, NY); Namita A. Gandhi (New York, NY); Robert Evans (New York, NY); Jennifer Hamilton (Hopewell Junction, NY)

Assignees: SANOFI BIOTECHNOLOGY; REGENERON PHARMACEUTICALS, INC.

A61K39/3955A61P11/02A61K2039/505A61K2039/545A61P11/06C07K14/7155C07K16/2866C07K2317/21C07K2317/76

Abstract

Claims (43)

1 . A method of treating inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in a subject in need thereof, the method comprising:

administering dupilumab subcutaneously to the subject at a dose of 300 mg;

wherein the dupilumab is administered as an add-on maintenance treatment;

wherein prior to the treatment the subject had a bilateral endoscopic nasal polyp score (NPS) of at least 5 points; and

wherein the subject achieves a decrease in NPS.

2 . The method of claim 1 , wherein the dose of 300 mg of the dupilumab is administered once a week or once every two weeks.

3 . The method of claim 2 , wherein the dose of 300 mg of the dupilumab is administered once every two weeks.

4 . The method of claim 3 , wherein the subject achieves a decrease in NPS of 1 point.

5 . The method of claim 4 , wherein the subject is on a background therapy comprising an intranasal corticosteroid (INCS).

6 . The method of claim 3 , wherein the subject achieves a decrease in NPS of 2 points.

7 . The method of claim 6 , wherein prior to the treatment the subject had at least 1 nasal surgery.

8 . A method of treating chronic rhinosinusitis with nasal polyps (CRSwNP) in a subject in need thereof, the method comprising administering dupilumab subcutaneously to the subject

at a dose of 300 mg once every two weeks.

9 . The method of claim 8 , wherein the subject is on a background therapy comprising an INCS.

10 . The method of claim 9 , wherein prior to the treatment the subject had loss of smell as measured by morning (AM) loss of smell score.

11 . The method of claim 10 , wherein the subject achieves a decrease in AM loss of smell score.

12 . The method of claim 11 , wherein prior to the treatment the subject had an AM loss of smell score of at least 2.

13 . The method of claim 12 , wherein the subject achieves a decrease in AM loss of smell score of at least 1 point.

14 . The method of claim 11 , wherein prior to the treatment the subject had at least 1 nasal surgery.

15 . The method of claim 11 , wherein the subject achieves a decrease in NPS.

16 . A method of treating inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in a subject in need thereof, the method comprising:

administering dupilumab subcutaneously to the subject at a dose of 300 mg;

wherein the dupilumab is administered as an add-on maintenance treatment;

wherein prior to the treatment the subject had a nasal congestion/obstruction (NC) score of at least 1 at baseline; and

wherein the subject achieves a decrease in NC score.

17 . The method of claim 16 , wherein the dose of 300 mg of dupilumab is administered once a week or once every 2 weeks.

18 . The method of claim 17 , wherein the dose of 300 mg of dupilumab is administered once every 2 weeks.

19 . The method of claim 18 , wherein the subject achieves an NC score of less than 1 point.

20 . The method of claim 19 , wherein prior to the treatment the subject had at least 1 nasal surgery.

21 . The method of claim 19 , wherein the subject achieves a decrease in NPS.

22 . The method of claim 18 , wherein the NC score is a morning (AM) NC score.

23 . The method of claim 18 , wherein the subject is on a background therapy comprising an INCS.

24 . A method of treating inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in a subject in need thereof, the method comprising:

administering dupilumab subcutaneously to the subject at a dose of 300 mg;

wherein the dupilumab is administered as an add-on maintenance treatment;

wherein prior to the treatment the subject had sinus opacification as measured by Lund-Mackay (LMK) sinus computed tomography (CT) scan total score; and

wherein the subject achieves a decrease in LMK sinus CT scan total score.

25 . The method of claim 24 , wherein the dose of 300 mg of dupilumab is administered once a week or once every 2 weeks.

26 . The method of claim 25 , wherein the dose of 300 mg of dupilumab is administered once every 2 weeks.

27 . The method of claim 26 , wherein prior to the treatment the subject had a LMK sinus CT scan total score of at least 18 points.

28 . The method of claim 27 , wherein the subject achieves a decrease in LMK sinus CT scan total score of at least 8 points.

29 . The method of claim 27 , wherein prior to the treatment the subject had at least 1 nasal surgery.

30 . The method of claim 27 , wherein the subject is on a background therapy comprising an INCS.

Assignments (3)

Priority Claims (1)

Continuity (7)

References Cited (400)