US 12,097,202 C1 (264th)
Methods of administering belumosudil for treatment of chronic graft versus host disease
David Eiznhamer, Cambridge, MA (US); and Heidi Krenz, Cambridge, MA (US)
Filed by Kadmon Corporation, LLC, Bridgewater, NJ (US)
Assigned to KADMON CORPORATION, LLC, Bridgewater, NJ (US)
Supplemental Examination Request No. 96/050,091, May 7, 2025.
Reexamination Certificate for Patent 12,097,202, issued Sep. 24, 2024, Appl. No. 18/105,285, Feb. 3, 2023.
Application 96/050,091 is a continuation of application No. PCT/US2022/037207, filed on Jul. 14, 2022.
Ex Parte Reexamination Certificate from Reexamination Ordered under 35 U.S.C. 257 issued on Jan. 30, 2026.
Int. Cl. A61K 31/517 (2006.01); A61K 9/20 (2006.01); A61P 37/06 (2006.01)
CPC A61K 31/517 (2013.01) [A61K 9/2009 (2013.01); A61K 9/2013 (2013.01); A61K 9/2027 (2013.01); A61K 9/2031 (2013.01); A61K 9/2054 (2013.01); A61P 37/06 (2018.01)]
AS A RESULT OF REEXAMINATION, IT HAS BEEN DETERMINED THAT:
Claims 2 and 5-6 were previously disclaimed.
Claim 1 is determined to be patentable as amended.
Claims 3 and 4, dependent on an amended claim, are determined to be patentable.
1. A method of treating chronic graft-versus-host disease (cGVHD) in a patient in need thereof comprising the steps of:
(a) administering 2-{3-[4-(1H-indazol-5-ylamino)-2-quinazolinyl] phenoxy}-N-(propan-2-yl) acetamide, or a pharmaceutically acceptable salt thereof (Compound) to the patient at a daily dose that is equivalent to 200 mg of the free base of the Compound;
(b) identifying an adverse reaction in the patient, wherein the adverse reaction is an [ a treatment-related ] infection;
(c) ceasing administration of the Compound to the patient when the adverse reaction is an infection at a Grade 3 level; wherein an [ a treatment-related ] infection at a Grade 3 level comprises an infection wherein intravenous (IV) antibiotic, antifungal, antiviral, radiological or operative intervention is indicated; and
(d) resuming administration of the Compound to the patient at the previously administered daily dose when the patient's [ treatment-related ] infection has recovered to Grade 1 level or less, wherein an infection at a Grade 1 level comprises an infection wherein intervention is not indicated.