	US 12,240,893 B2
	Subcutaneous dosage and administration of anti-C5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (PNH)
Lori Volles, New Haven, CT (US); Rajendra Pradhan, New Haven, CT (US); Douglas L. Sheridan, Branford, CT (US); Marc Vallee, Lexington, MA (US); and Xiang Gao, Guilford, CT (US)
Assigned to Alexion Pharmaceuticals, Inc., Boston, MA (US)
Appl. No. 17/289,178
Filed by Alexion Pharmaceuticals, Inc., Boston, MA (US)
PCT Filed Oct. 30, 2019, PCT No. PCT/US2019/058846 § 371(c)(1), (2) Date Apr. 27, 2021, PCT Pub. No. WO2020/092549, PCT Pub. Date May 7, 2020.
Claims priority of provisional application 62/752,563, filed on Oct. 30, 2018.
Prior Publication US 2021/0395352 A1, Dec. 23, 2021
Int. Cl. A61K 39/00 (2006.01); A61P 7/00 (2006.01); C07K 16/18 (2006.01)

CPC C07K 16/18 (2013.01) [A61P 7/00 (2018.01); A61K 2039/505 (2013.01); A61K 2039/545 (2013.01); C07K 2317/52 (2013.01); C07K 2317/565 (2013.01); C07K 2317/92 (2013.01); C07K 2317/94 (2013.01)]

19 Claims

1. A method of treating a human patient with Paroxysmal Nocturnal Hemoglobinuria (PNH), the method comprising administering to the patient during an administration cycle an effective amount of an anti-C5 antibody, or antigen binding fragment thereof, comprising CDR1, CDR2, and CDR3 heavy chain sequences as set forth in SEQ ID NOs: 19, 18, and 3, respectively, and CDR1, CDR2, and CDR3 light chain sequences as set forth in SEQ ID NOs: 4, 5, and 6, respectively, wherein the anti-C5 antibody, or antigen binding fragment thereof, is administered:

(a) intravenously once on Day 1 of the administration cycle at a dose of:

i. 2400 mg to a patient weighing ≥40 to <60 kg, or

ii. 2700 mg to a patient weighing ≥60 to <100 kg; and

(b) subcutaneously on Day 15 of the administration cycle and every week thereafter at a dose of 490 mg.