	US 12,404,320 B2
	Dosage and administration of anti-C5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (PNH) in pediatric patients
Lori Payton, Madison, CT (US); Scott T. Rottinghaus, Salem, CT (US); Rajendra Pradhan, New Haven, CT (US); Stephan Ortiz, Wellesley, MA (US); Masayo Ogawa, Woodbridge, CT (US); and Xiang Gao, Guilford, CT (US)
Assigned to Alexion Pharmaceuticals, Inc., Boston, MA (US)
Appl. No. 17/057,867
Filed by Alexion Pharmaceuticals, Inc., Boston, MA (US)
PCT Filed May 29, 2019, PCT No. PCT/US2019/034293 § 371(c)(1), (2) Date Nov. 23, 2020, PCT Pub. No. WO2019/231893, PCT Pub. Date Dec. 5, 2019.
Claims priority of provisional application 62/678,455, filed on May 31, 2018.
Prior Publication US 2021/0214425 A1, Jul. 15, 2021
Int. Cl. C07K 16/18 (2006.01); A61K 9/00 (2006.01); A61P 7/00 (2006.01); C07K 16/28 (2006.01); A61K 39/00 (2006.01)

CPC C07K 16/18 (2013.01) [A61K 9/0019 (2013.01); A61P 7/00 (2018.01); C07K 16/283 (2013.01); A61K 2039/505 (2013.01); A61K 2039/54 (2013.01); A61K 2039/545 (2013.01); A61K 2039/55 (2013.01); C07K 2317/24 (2013.01); C07K 2317/52 (2013.01); C07K 2317/565 (2013.01); C07K 2317/76 (2013.01); C07K 2317/92 (2013.01)]

12 Claims

1. A method of treating a human pediatric patient with Paroxysmal Nocturnal Hemoglobinuria (PNH), the method comprising administering to the patient an effective amount of an anti-C5 antibody comprising heavy and light chains comprising the amino acid sequences shown in SEQ ID NOs:14 and 11, respectively, wherein the anti-C5 antibody is administered intravenously:

(a) once on Day 1 at a dose of 600 mg to a patient weighing ≥5 to <10 kg, 600 mg to a patient weighing ≥10 to <20 kg, 900 mg to a patient weighing ≥20 to <30 kg, or 1200 mg to a patient weighing ≥30 to <40 kg; and

(b) on Day 15 and every four weeks thereafter at a dose of 300 mg to a patient weighing ≥5 to <10 kg or 600 mg to a patient weighing ≥10 to <20 kg; or on Day 15 and every eight weeks thereafter at a dose of 2100 mg to a patient weighing ≥20 to <30 kg, or 2700 mg to a patient weighing ≥30 to <40 kg.