Back to results
US 2017/0281734 A1Published application
Factor viii polypeptide formulations
AssigneeBioverativ Therapeutics Inc.
InventorsKevin MALONEY, Daniel Gage, Ahmad Abdul-Fattah
Life of this patent
Estimating the term…
Abstract
The present invention provides a formulation of a Factor VIII polypeptide, e.g., FVIII-Fc, and methods of using the same. The FVIII polypeptide can be a recombinant FVIII protein, a short-acting FVIII protein, or a long-acting FVIII protein. The pharmaceutical formulation comprising a FVIII polypeptide can be used for individual prophylaxis, weekly prophylaxis, episodic (on-demand) treatment, or perioperative management of hemophilia.
Claims21
1-116. (canceled)
A pharmaceutical composition comprising:
- (a) a long-acting FVIII polypeptide;
- (b) one or more stabilizing agents selected from the group consisting of sucrose, trehalose, raffinose, arginine, and mixture thereof;
- (c) sodium chloride (NaCl);
- (d) L-histidine;
- (e) calcium chloride;
- and
- (f) 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) a long-acting FVIII polypeptide,
- (ii) one or more stabilizing agents selected from the group consisting of sucrose, trehalose, raffinose, arginine, and mixture thereof;
- (iii) sodium chloride (NaCl);
- (iv) L-histidine;
- (v) calcium chloride;
- and
- (vi) polysorbate 20 or polysorbate 80;
- and
- (b) a second container comprising sterilized water for injections to be combined with the lyophilized powder of the first container.
7 more elements
Dependencies are inferred from the claim text.