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US 2020/0399363 A1Published application
Pharmaceutical formulations of fcrn inhibitors suitable for subcutaneous administration
Assigneeargenx BVBA
InventorFilip Borgions
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Assigneeargenx BVBA
InventorFilip Borgions
Estimating the term…
Provided are various aqueous formulations of the neonatal Fc receptor (FcRn) antagonist ARGX-113, including formulations useful as pharmaceutical compositions, methods for their preparation, devices comprising the various formulations, and uses thereof. In certain embodiments the formulations are suitable and useful for administration of ARGX-113 to a human subject. In certain embodiments the formulations are suitable and useful for subcutaneous administration of ARGX-113 to a human subject. The formulations can be used in the treatment of any condition that would benefit from inhibition of FcRn-mediated antibody recycling. Such conditions can include any one or more of various antibody-mediated autoimmune diseases, including, for example and without limitation, myasthenia gravis (MG) and immune thrombocytopenia (ITP).
An aqueous formulation comprising about 100-300 mg/mL of an isolated neonatal Fc receptor (FcRn) antagonist in 20-60 mM histidine/histidine HCl, 0-70 mM sucrose, 0-150 mM NaCl, 0-250 mM arginine HCl, 0.02%-0.05% (w/v) polysorbate 20 or polysorbate 80, 0-15 mM L-methionine, pH 6.0-6.5, wherein the isolated FcRn antagonist consists of a variant Fc region, wherein said variant Fc region consists of two Fc domains which form a homodimer, wherein the amino acid sequence of each of the Fc domains consists of SEQ ID NO:
An aqueous formulation comprising 175 mg/mL ARGX-113 in 20 mM histidine/histidine HCl, 60 mM sucrose, 100 mM arginine HCl, 10 mM L-methionine, and 0.03% (w/v) polysorbate 20, pH 6.0, wherein ARGX-113 is the isolated FcRn antagonist, wherein the amino acid sequence of each of the Fc domains consists of SEQ ID NO:
Dependencies are inferred from the claim text.