	US 12,460,012 B2
	Dosage and administration of anti-C5 antibodies for treatment of atypical hemolytic uremic syndrome (aHUS) in pediatric patients
Lori Payton, Madison, CT (US); Andrew Denker, Ardmore, PA (US); Eugene Scott Swenson, Madison, CT (US); Rajendra Pradhan, New Haven, CT (US); Stephan Ortiz, Guilford, CT (US); Marc Vallee, Lexington, MA (US); Christian Mix, Wellesley, MA (US); and Xiang Gao, Guilford, CT (US)
Assigned to Alexion Pharmaceuticals, Inc., Boston, MA (US)
Appl. No. 17/057,898
Filed by ALEXION PHARMACEUTICALS, INC., Boston, MA (US)
PCT Filed May 29, 2019, PCT No. PCT/US2019/034297 § 371(c)(1), (2) Date Nov. 23, 2020, PCT Pub. No. WO2019/236345, PCT Pub. Date Dec. 12, 2019.
Claims priority of provisional application 62/790,577, filed on Jan. 10, 2019.
Claims priority of provisional application 62/680,121, filed on Jun. 4, 2018.
Prior Publication US 2021/0332147 A1, Oct. 28, 2021
Int. Cl. A61P 7/00 (2006.01); C07K 16/28 (2006.01); A61K 39/00 (2006.01)

CPC C07K 16/2896 (2013.01) [A61P 7/00 (2018.01); A61K 2039/505 (2013.01); A61K 2039/545 (2013.01); C07K 2317/34 (2013.01); C07K 2317/52 (2013.01); C07K 2317/76 (2013.01); C07K 2317/94 (2013.01)]

15 Claims

1. A method of treating a human pediatric patient who is less than 18 years of age and has Atypical Hemolytic Uremic Syndrome (aHUS), the method comprising administering to the patient an effective amount of an anti-C5 antibody comprising a heavy chain comprising the amino acid sequence set forth in SEQ ID NO:14 and a light chain comprising the amino acid sequence set forth in SEQ ID NO:11, wherein the anti-C5 antibody or antigen binding fragment thereof, is administered:

(a) once on Day 1 at a loading dose of:

i. 600 mg to a patient weighing ≥5 to <10 kg,

ii. 600 mg to a patient weighing ≥10 to <20 kg,

iii. 900 mg to a patient weighing ≥20 to <30 kg,

iv. 1200 mg to a patient weighing ≥30 to <40 kg; and

(b) on Day 15 at a maintenance dose of:

i. 300 mg to a patient weighing ≥5 to <10 kg,

ii. 600 mg to a patient weighing ≥10 to <20 kg,

iii. 2100 mg to a patient weighing ≥20 to <30 kg,

iv. 2700 mg to a patient weighing ≥30 to <40 kg,

wherein patients weighing <20 kg receive additional maintenance doses every four weeks thereafter, and patients weighing ≥20 kg receive additional maintenance doses every eight weeks thereafter, and

wherein the treatment maintains a serum trough concentration of the anti-C5 antibody or antigen binding fragment thereof of 100 μg/mL or greater and/or a free C5 concentration of 0.5 μg/mL or lower.