Claims for Patent: 10,000,565

Summary for Patent: 10,000,565

Title:	Use of IL-1 .beta. binding antibodies for treating peripheral arterial disease
Abstract:	The present invention relates to a method for treating or alleviating the symptoms of peripheral arterial disease (PAD) in a subject, comprising administering about 25 mg to about 300 mg of an IL-1.beta. binding antibody or functional fragment thereof.
Inventor(s):	Basson; Craig (Needham, MA), Fishman; Mark (Newton Center, MA), Thuren; Tom (Succasunna, NJ), Foo; Shi Yin (Brookline, MA)
Assignee:	Novartis AG (Basel, CH)
Application Number:	14/442,536
Patent Claims:	1. A method for treating or alleviating the symptoms of peripheral arterial disease (PAD), comprising administering a subcutaneous dose of about 150 mg to about 300 mg of an IL-1.beta. binding antibody to a subject having symptomatic intermittent claudication and PAD, said subject exhibiting an ankle-brachial index less than 0.9 in at least one leg before treatment, wherein the antibody is administered every month, every two months, or every three months, and wherein the antibody comprises: a) a V.sub.H domain comprising the amino acid sequence set forth in SEQ ID NO:1 and a V.sub.L domain comprising the amino acid sequence set forth in SEQ ID NO:2; or b) a V.sub.H domain comprising complementarity determining regions (CDRs) 1-3, wherein CDR1 comprises the amino acid sequences set forth as SEQ ID NO:3, CDR2 comprises the amino acid sequences set forth as SEQ ID NO:4, and CDR3 comprises the amino acid sequences set forth as SEQ ID NO:5, and a V.sub.L domain comprising CDRs1-3 wherein CDR1 comprises the amino acid sequences set forth as SEQ ID NO:6, CDR2 comprises the amino acid sequences set forth as SEQ ID NO:7, and CDR3 comprises the amino acid sequences set forth as SEQ ID NO:8. 2. The method according to claim 1, wherein the subject is exhibiting an ankle-brachial index between 0.5 and 0.85 in at least one leg before treatment. 3. The method according to claim 1, wherein the subject has improved vascular structure and function after 3 months of treatment. 4. The method according to claim 1, wherein reduced plaque burden in the peripheral artery walls of said subject is observed after at least 3 months of treatment. 5. The method according to claim 1, wherein a reduced plaque burden compared to before treatment in said subject is determined in the superficial femoral artery after at least 3 months of treatment. 6. The method according to claim 1, wherein a reduced plaque burden compared to before treatment in said subject is determined in the superficial femoral artery after at least 12 months of treatment. 7. The method according to claim 1, wherein said IL-1.beta. binding antibody is administered for a duration of at least one year. 8. The method according to claim 1, wherein the dose of the IL-1.beta. binding antibody is about 150 mg. 9. The method according to claim 1, wherein the dose of the IL-1.beta. binding antibody is about 300 mg. 10. The method according to claim 1, wherein the IL-1.beta. binding antibody is capable of inhibiting the binding of IL-1.beta. to its receptor and has a K.sub.D for binding to IL-1.beta. of about 50 pM or less. 11. The method according to claim 1, wherein said IL-1.beta. binding antibody is canakinumab. 12. The method according to claim 11, wherein canakinumab is administered in a liquid formulation comprising 10-200 mg/ml canakinumab, mannitol, histidine and polysorbate 80, wherein the pH of the formulation is 6.1-6.9. 13. The method according to claim 1, wherein said IL-1.beta. binding antibody is provided for administration to the patient in liquid form in a prefilled syringe or lyophilized form for reconstitution in a prefilled syringe. 14. The method according to claim 1, wherein said patient is concomitantly receiving a statin. 15. The method according to claim 1, wherein said patient is concomitantly receiving a beta-adrenergic blocking drug, an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker.

Details for Patent 10,000,565

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Novartis Pharmaceuticals Corporation	ILARIS	canakinumab	For Injection	125319	06/17/2009		2039-02-26
Novartis Pharmaceuticals Corporation	ILARIS	canakinumab	Injection	125319	12/22/2016		2039-02-26