Anti-CGRP Antibody Formulation

Abstract

Pharmaceutical formulations for anti-CGRP antibodies, and methods of using the same, are provided which are useful as treatment for migraines, episodic headaches, chronic headaches, chronic cluster headaches, and episodic cluster headaches.

1 - 41 . (canceled) 
     
     
         42 . A pharmaceutical formulation comprising:
 (a) from 50 mg/mL to 160 mg/mL of an anti-CGRP antibody, wherein the anti-CGRP antibody comprises two light chains (LCs) and two heavy chains (HCs), the amino acid sequence of each LC given by SEQ ID NO: 3 and the amino acid sequence of each HC given by SEQ ID NO: 4;   (b) from 5 mM to 20 mM of histidine buffer;   (c) from 50 mM to 200 mM of NaCl;   (d) from 0.03% (w/v) to 0.07% (w/v) of polysorbate-80 (PS-80); and   (e) a pH from 5.0 to 6.5.   
     
     
         43 . The formulation of  claim 42 , wherein the formulation comprises from 100 mg/mL to 160 mg/mL of the anti-CGRP antibody. 
     
     
         44 . The formulation of  claim 43 , wherein the formulation comprises 100 mg/mL of the anti-CGRP antibody. 
     
     
         45 . The formulation of  claim 43 , wherein the formulation comprises 120 mg/mL of the anti-CGRP antibody. 
     
     
         46 . The formulation of  claim 42 , wherein the formulation comprises from 10 mM to 15 mM of the histidine buffer. 
     
     
         47 . The formulation of  claim 44 , wherein the formulation comprises 10 mM of the histidine buffer. 
     
     
         48 . The formulation of  claim 45 , wherein the formulation comprises 10 mM of the histidine buffer. 
     
     
         49 . The formulation of claim  1 , wherein the formulation comprises 150 mM of the NaCl. 
     
     
         50 . The formulation of  claim 47 , wherein the formulation comprises 150 mM of the NaCl. 
     
     
         51 . The formulation of  claim 48 , wherein the formulation comprises 150 mM of the NaCl. 
     
     
         52 . The formulation of  claim 42 , wherein the formulation comprises 0.05% (w/v) of the PS-80. 
     
     
         53 . The formulation of  claim 50 , wherein the formulation comprises 0.05% (w/v) of the PS-80. 
     
     
         54 . The formulation of  claim 51 , wherein the formulation comprises 0.05% (w/v) of the PS-80. 
     
     
         55 . The formulation of  claim 42 , wherein the pH is from 5.5 to 6. 
     
     
         56 . The formulation of  claim 53 , wherein the pH is from 5.5 to 6. 
     
     
         57 . The formulation of  claim 54 , wherein the pH is from 5.5 to 6. 
     
     
         58 . The formulation of  claim 42 , wherein the formulation is suitable for subcutaneous injection. 
     
     
         59 . The formulation of  claim 58 , wherein the formulation is suitable for subcutaneous injection when the formulation is stored in a prefilled syringe for 3 months at 25° C. 
     
     
         60 . The formulation of  claim 58 , wherein the formulation is suitable for subcutaneous injection when the formulation is stored in a prefilled syringe for 1 month at 40° C. 
     
     
         61 . The formulation of  claim 58 , wherein the formulation has greater than 16% (w/v) of the PS-80 remaining when the formulation is stored in a prefilled syringe for 3 months at 25° C. 
     
     
         62 . The formulation of  claim 61 , wherein the formulation has greater than 12% (w/v) of the PS-80 remaining when the formulation is stored in a prefilled syringe for 6 months at 25° C. 
     
     
         63 . The formulation of  claim 58 , wherein the formulation has greater than 58% (w/v) of the PS-80 remaining when the formulation is stored in a prefilled syringe for 1 month at 40° C. 
     
     
         64 . A pharmaceutical formulation comprising:
 (a) from 50 mg/mL to 160 mg/mL of an anti-CGRP antibody, wherein the anti-CGRP antibody comprises two light chains (LCs) and two heavy chains (HCs), the amino acid sequence of each LC given by SEQ ID NO: 3 and the amino acid sequence of each HC given by SEQ ID NO: 4;   (b) 10 mM of histidine buffer;   (c) 150 mM of NaCl;   (d) 0.05% (w/v) of polysorbate-80 (PS-80); and   (e) a pH from 5.5 to 6.   
     
     
         65 . The formulation of  claim 64 , wherein the formulation comprises 100 mg/mL or 120 mg/mL of the anti-CGRP antibody. 
     
     
         66 . The formulation of  claim 65 , wherein the pH is 5.8. 
     
     
         67 . The formulation of  claim 66 , wherein the formulation is suitable for subcutaneous injection. 
     
     
         68 . The formulation of  claim 67 , wherein the formulation is suitable for subcutaneous injection when the formulation is stored in a prefilled syringe for 3 months at 25° C. 
     
     
         69 . The formulation of  claim 67 , wherein the formulation is suitable for subcutaneous injection when the formulation is stored in a prefilled syringe for 1 month at 40° C. 
     
     
         70 . The formulation of  claim 67 , wherein the formulation has greater than 16% (w/v) of the PS-80 remaining when the formulation is stored in a prefilled syringe for 3 months at 25° C. 
     
     
         71 . The formulation of  claim 70 , wherein the formulation has greater than 12% (w/v) of the PS-80 remaining when the formulation is stored in a prefilled syringe for 6 months at 25° C. 
     
     
         72 . The formulation of  claim 67 , wherein the formulation has greater than 58% (w/v) of the PS-80 remaining when the formulation is stored in a prefilled syringe for 1 month at 40° C.