Claims for Patent: 10,392,434

Summary for Patent: 10,392,434

Title:	Treating refractory migraine
Abstract:	Disclosed herein are methods of treating or reducing incidence of migraine and/or at least one secondary symptom associated with refractory migraine in a subject having refractory migraine comprising administering to the subject a monoclonal antibody that modulates the CGRP pathway. Compositions for use in the disclosed methods are also provided. Antagonist antibody G1 and antibodies derived from G1 directed to CGRP are also described.
Inventor(s):	Bigal; Marcelo (Doylestown, PA), Aycardi; Ernesto (Andover, MA)
Assignee:	Teva Pharmaceuticals International GmbH (Jona, CH)
Application Number:	15/712,444
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,392,434
Patent Claims:	1. A method of treating migraine in a subject, the method comprising: selecting a subject who has an inadequate response to two or more different classes of preventative migraine treatment selected from the group consisting of beta-blockers, anticonvulsants, tricyclics, calcium channel blockers, angiotensin II receptor antagonists, onabotulinumtoxinA, and valproates; and administering to the subject a therapeutically effective amount of a humanized monoclonal anti-calcitonin gene-related peptide (CGRP) antagonist antibody comprising the amino acid sequence of the heavy chain variable region set forth in SEQ ID NO: 1 and the amino acid sequence of the light chain variable region set forth in SEQ ID NO: 2. 2. The method of claim 1, wherein the subject is human. 3. The method of claim 1, wherein the monoclonal antibody is administered at a dose of about 225 mg followed by subsequent doses of about 225 mg at one month intervals. 4. The method of claim 1, wherein the administering comprises administering the antibody to the subject from a pre-filled syringe, pre-filled syringe with a needle safety device, injection pen, or auto-injector comprising a dose of the monoclonal antibody. 5. The method of claim 1, wherein the monoclonal antibody is administered as a formulation comprising the antibody at a concentration of at least about 150 mg/mL. 6. The method of claim 1, wherein the monoclonal antibody is administered in a volume of less than 2 mL. 7. The method of claim 1, comprising administering to the subject a second agent simultaneously or sequentially with the monoclonal antibody, wherein the second agent is an acute headache medication. 8. The method of claim 7, wherein monthly use of the second agent by the subject is decreased by at least 15% after administering the monoclonal antibody. 9. The method of claim 1, wherein the monoclonal antibody is administered at a dose of about 675 mg. 10. The method of claim 9, wherein the dose of about 675 mg is administered as three separate injections of about 225 mg each. 11. The method of claim 1, wherein the monoclonal antibody is administered at a dose of about 675 mg followed by subsequent doses of about 675 mg administered every quarter. 12. The method of claim 11, wherein the monoclonal antibody is administered subcutaneously. 13. The method of claim 11, wherein the dose of about 675 mg is administered as three separate injections of about 225 mg each.

Details for Patent 10,392,434

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Allergan, Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000	12/09/1991		2036-09-23
Allergan, Inc.	BOTOX	onabotulinumtoxina	For Injection	103000	12/09/1991		2036-09-23