Antagonist antibodies directed against calcitonin gene-related peptide and methods using same
The invention features methods for preventing or treating CGRP associated disorders such as vasomotor symptoms and/or headaches (e.g., migraine, cluster headache, and tension headache) by administering an anti-CGRP antagonist antibody. Compositions for use in the disclosed methods are also provided. Antagonist antibody G1 and antibodies derived from G1 directed to CGRP are also described.
1. A method of treating or reducing incidence of headache in a subject, the method comprising:
administering to the subject an amount of a monoclonal antibody that inhibits the calcitonin gene-related peptide (CGRP) pathway,
wherein the monoclonal antibody comprises a CDR H1 as set forth in SEQ ID NO:3; a CDR H2 as set forth in SEQ ID NO:4; a CDR H3 as set forth in SEQ ID NO:5; a CDR L1 as set forth in SEQ ID NO:6; a CDR L2 as set forth in SEQ ID NO:7; and a CDR L3 as set forth in SEQ ID NO:8,
wherein the monoclonal antibody is administered at a dose of about 225 mg at one month intervals, and
wherein the monoclonal antibody is formulated at a concentration of at least 150 mg/mL, thereby treating or reducing incidence of headache in the subject.
2. The method of claim 1 , wherein the administering is subcutaneous or intravenous administration.
3. The method of claim 1 , wherein the subject is human.
4. The method of claim 1 , wherein the monoclonal antibody is human or humanized.
5. The method of claim 1 , wherein the headache is migraine headache.
6. The method of claim 5 , wherein the migraine headache is chronic migraine headache.
7. The method of claim 5 , wherein the migraine headache is episodic migraine headache.
8. The method of claim 1 , wherein the administering comprises utilizing a pre-filled syringe comprising the amount of the monoclonal antibody.
9. The method of claim 1 , wherein the monoclonal antibody is administered in a volume of about 1.5 mL.
10. A method of treating or reducing incidence of headache in a subject, the method comprising:
administering to the subject an amount of a monoclonal antibody that inhibits the calcitonin gene-related peptide (CGRP) pathway,
wherein the monoclonal antibody comprises a CDR H1 as set forth in SEQ ID NO:3; a CDR H2 as set forth in SEQ ID NO:4; a CDR H3 as set forth in SEQ ID NO:5; a CDR L1 as set forth in SEQ ID NO:6; a CDR L2 as set forth in SEQ ID NO:7; and a CDR L3 as set forth in SEQ ID NO:8,
wherein the monoclonal antibody is administered at a dose of about 225 mg at one month intervals, and
wherein the monoclonal antibody is administered in a volume of less than 2 mL, thereby treating or reducing incidence of headache in the subject.
11. The method of claim 10 , wherein the administering is subcutaneous or intravenous administration.
12. The method of claim 10 , wherein the monoclonal antibody is formulated at a concentration of at least 150 mg/mL.
13. The method of claim 10 , wherein the subject is human.
14. The method of claim 10 , wherein the monoclonal antibody is human or humanized.
15. The method of claim 10 , wherein the headache is migraine headache.
16. The method of claim 15 , wherein the migraine headache is chronic migraine headache.
17. The method of claim 15 , wherein the migraine headache is episodic migraine headache.
18. The method of claim 10 , wherein the administering comprises utilizing a pre-filled syringe comprising the amount of the monoclonal antibody.
19. The method of claim 10 , wherein the monoclonal antibody is administered in a volume of about 1.5 mL.