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US 10,588,949 B2Granted
Factor IX polypeptide formulations
AssigneeBioverativ Therapeutics Inc.
InventorMark Brader
Life of this patent
Estimating the term…
Abstract
The present invention provides formulations comprising a Factor IX-FcRn Binding Partner (FIXFBP) polypeptide, and methods of administering FIXFBP.
Claims42
A pharmaceutical composition comprising:
- (a) a rFIXFc polypeptide comprising human FIX fused to a Fc domain of a human antibody;
- (b) between about 10 mg/ml and about 20 mg/ml of sucrose;
- (c) between about 20 mg/ml and about 40 mg/ml of mannitol
- (d) between about 3 mg/ml and about 4 mg/ml of sodium chloride (NaCl);
- (e) between about 3 mg/ml and about 6 mg/ml of L-histidine;
- and
- (f) between about 0.08 mg/ml and about 0.2 mg/ml of polysorbate 20 or polysorbate 80.
4 more elements
A pharmaceutical kit comprising:
- (a) a first container comprising a lyophilized powder, where the powder comprises
- (i) about 200 IU to about 4000 IU of a rFIXFc polypeptide comprising human Factor IX fused to a Fc domain of a human antibody;
- (ii) about 59.5 mg or about 83.3 mg of sucrose;
- (iii) about 119 mg or about 167 mg of mannitol;
- (iv) about 19.4 mg or about 27.2 mg of L-histidine;
- and
- (v) about 0.50 mg or about 0.7 mg of polysorbate 20 or polysorbate 80;
- and
- (b) a second container comprising 0.325% (w/v) NaCl to be combined with the lyophilized powder of the first container.
6 more elements
A pharmaceutical composition comprising:
- (a) between about 25 IU/ml and about 700 IU/ml of a rFIXFc polypeptide comprising human Factor IX fused to a Fc domain of a human antibody;
- (b) between about 10 mg/ml and about 20 mg/ml of sucrose;
- (c) between about 20 mg/ml and about 40 mg/ml of mannitol;
- (d) between about 3 mg/ml and about 4 mg/ml of NaCl;
- (e) between about 3 mg/ml and about 6 mg/ml of L-histidine;
- and
- (f) between about 0.08 mg/ml and about 0.15 mg/ml of polysorbate-20 or polysorbate-80.
4 more elements
A pharmaceutical kit comprising:
- (a) a first container comprising a lyophilized powder, where the powder comprises
- (i) 200 IU to 4000 IU of a rFIXFc protein comprising human coagulation Factor IX (FIX) and a Fc domain of a human antibody,
- wherein the rFIXFc protein comprises a first subunit comprising amino acids 1 to 642 of SEQ ID NO:2 and a second subunit comprising amino acids 1 to 227 of SEQ ID NO:4,
- (ii) 59.5 mg or 83.3 mg of sucrose,
- (iii) 119 mg or 167 mg of mannitol,
- (iv) 19.4 mg or 27.2 mg of L-histidine, and
- (v) 0.50 mg or 0.7 mg of polysorbate 20;
- and
- (b) a second container comprising 0.325% (w/v) NaCl to be combined with the lyophilized powder of the first container.
6 more elements
A pharmaceutical composition comprising:
- (a) 25 IU/ml to 700 IU/ml of a rFIXFc protein comprising human coagulation Factor IX (FIX) and a Fc domain of a human antibody,
- wherein the rFIXFc protein comprises a first subunit comprising amino acids 1 to 642 of SEQ ID NO:2 and a second subunit comprising amino acids 1 to 227 of SEQ ID NO:4;
- (b) 10 mg/ml to 20 mg/ml of sucrose;
- (c) 20 mg/ml to 40 mg/ml of mannitol;
- (d) 3 mg/ml to 4 mg/ml of NaCl;
- (e) 3 mg/ml to 6 mg/ml of L-histidine;
- and
- (f) 0.08 mg/ml to 0.15 mg/ml of polysorbate 20.
5 more elements
Dependencies are inferred from the claim text.