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 . (cancelled) 
     
     
         42 . A method of treating or preventing migraines, episodic headaches, chronic headaches, chronic cluster headaches, or episodic cluster headaches comprising administering to a patient a therapeutically effective amount of a pharmaceutical formulation comprising an anti-CGRP antibody at a concentration of about 40 mg/mL to about 160 mg/mL, histidine buffer at a concentration of about 5 mM to about 20 mM, NaCl at a concentration of about 50 mM to about 200mM, PS-80 at a concentration of about 0.03% (w/v) to about 0.07% (w/v), and a pH at about 5.0 to about 6.5, wherein the anti-CGRP antibody comprises a light chain variable region (LCVR) and a heavy chain variable region (HCVR), the amino acid sequence of LCVR given by SEQ ID NO: 1 and the amino acid sequence of HCVR given by SEQ ID NO:  2 . 
     
     
         43 . The method of  claim 42 , wherein the dose of anti-CGRP antibody administered to a patient is about 300 mg. 
     
     
         44 . The method of  claim 42 , wherein the dose of anti-CGRP antibody administered to a patient is about 240 mg. 
     
     
         45 . The method of  claim 42 , wherein the dose of anti-CGRP antibody administered to a patient is about 120 mg. 
     
     
         46 . The method of  claim 44 , wherein the 240 mg dose is followed by a monthly maintenance dose of 120 mg. 
     
     
         47 . The method according to  claim 43 , wherein the dose is administered at weekly, semi-monthly or monthly intervals. 
     
     
         48 . The method according to  claim 44 , wherein the dose is administered at weekly, semi-monthly or monthly intervals. 
     
     
         49 . The method according to  claim 45 , wherein the dose is administered at weekly, semi-monthly or monthly intervals. 
     
     
         50 . A method to treat or prevent episodic or chronic migraine in a patient comprising administering a monthly subcutaneous dose of 120 mg of an anti-CGRP antibody, wherein the anti-CGRP antibody comprises a LC given by the amino acid sequence of SEQ ID NO: 3 and a HC given by the amino acid of SEQ ID NO: 4. 
     
     
         51 . A method to treat or prevent episodic or chronic migraine in a patient comprising administering a monthly subcutaneous dose of 240 mg of an anti-CGRP antibody, wherein the anti-CGRP antibody comprises a LC given by the amino acid sequence of SEQ ID NO: 3 and a HC given by the amino acid of SEQ ID NO: 4. 
     
     
         52 . A method to treat or prevent episodic or chronic migraine in a patient comprising administering a monthly subcutaneous dose of 240 mg of an anti-CGRP antibody followed by a monthly maintenance dose of 120 mg of the anti-CGRP antibody, wherein the anti-CGRP antibody comprises a LC given by the amino acid sequence of SEQ ID NO: 3 and a HC given by the amino acid of SEQ ID NO: 4. 
     
     
         53 . A method to treat or prevent cluster headache in a patient comprising administering a monthly subcutaneous dose of 300 mg of an anti-CGRP antibody, wherein the anti-CGRP antibody comprises a LC given by the amino acid sequence of SEQ ID NO: 3 and a HC given by the amino acid of SEQ ID NO: 4. 
     
     
         54 . The method according to  claim 50 , wherein the anti-CGRP antibody is in a pharmaceutical formulation comprising a histidine buffer. 
     
     
         55 . The method according to  claim 51 , wherein the anti-CGRP antibody is in a pharmaceutical formulation comprising a histidine buffer. 
     
     
         56 . The method according to  claim 52 , wherein the anti-CGRP antibody is in a pharmaceutical formulation comprising a histidine buffer. 
     
     
         57 . The method according to  claim 53 , wherein the anti-CGRP antibody is in a pharmaceutical formulation comprising a histidine buffer. 
     
     
         58 . The method according to  claim 54 , wherein the histidine buffer is at a concentration of about 10 mM to about 15 mM. 
     
     
         59 . The method according to  claim 55 , wherein the histidine buffer is at a concentration of about 10 mM to about 15 mM. 
     
     
         60 . The method according to  claim 56 , wherein the histidine buffer is at a concentration of about 10 mM to about 15 mM. 
     
     
         61 . The method according to  claim 57 , wherein the histidine buffer is at a concentration of about 10 mM to about 15 mM. 
     
     
         62 . The method according to  claim 58 , wherein the anti-CGRP antibody is in a pharmaceutical formulation at a pH of about 5.7-6.0. 
     
     
         63 . The method according to  claim 59 , wherein the anti-CGRP antibody is in a pharmaceutical formulation at a pH of about 5.7-6.0. 
     
     
         64 . The method according to  claim 60 , wherein the anti-CGRP antibody is in a pharmaceutical formulation at a pH of about 5.7-6.0. 
     
     
         65 . The method according to  claim 61 , wherein the anti-CGRP antibody is in a pharmaceutical formulation at a pH of about 5.7-6.0. 
     
     
         66 . The method according to  claim 62 , wherein the pharmaceutical formulation has a pH of about 5.8. 
     
     
         67 . The method according to  claim 63 , wherein the pharmaceutical formulation has a pH of about 5.8. 
     
     
         68 . The method according to  claim 64 , wherein the pharmaceutical formulation has a pH of about 5.8. 
     
     
         69 . The method according to  claim 65 , wherein the pharmaceutical formulation has a pH of about 5.8. 
     
     
         70 . The method according to  claim 50 , wherein the anti-CGRP antibody is in a pharmaceutical formulation comprising about 10mM histidine buffer, about 150mM NaCl, about 0.05% PS-80, and has a pH of about 5.8. 
     
     
         71 . The method according to  claim 51 , wherein the anti-CGRP antibody is in a pharmaceutical formulation comprising about 10 mM histidine buffer, about 150 mM NaCl, about 0.05% PS-80, and has a pH of about 5.8. 
     
     
         72 . The method according to  claim 52 , wherein the anti-CGRP antibody is in a pharmaceutical formulation comprising about 10 mM histidine buffer, about 150 mM NaC1, about 0.05% PS-80, and has a pH of about 5.8. 
     
     
         73 . The method according to  claim 53 , wherein the anti-CGRP antibody is in a pharmaceutical formulation comprising about 10 mM histidine buffer, about 150 mM NaC1, about 0.05% PS-80, and has a pH of about 5.8.