Subcutaneous administration of alpha-galactosidase a
AssigneeShire Human Genetic Therapies, Inc.
InventorsLisa Marie Sturk, Justin C. Lamsa, Michael W. Heartlein, Vinh Nguyen, Katherine D. Taylor, Zahra Shahrokh
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Abstract
The invention relates, in part, to improved methods of administering α-galactosidase A for the treatment of α-galactosidase A deficiencies including Fabry disease.
Claims29
A composition comprising from about 1 mg/ml to about 60 mg/ml alpha-galactosidase A (α-Gal from about 2% to about 10% (w/v) carbohydrate, from about 5 mM to about 10 mM citrate, up to 3% (v/v) excipient, from about 0.05% to about 0.5% (v/v) surfactant, and having a pH of 6.0.
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A method of enhancing delivery of alpha-galactosidase A (α-Gal A) to the kidneys in an individual with Fabry disease, the method comprising administering human α-Gal A subcutaneously or by an oral route or by a parenteral route to the individual.
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A method of producing therapeutically effective kidney levels of alpha-galactosidase A (α-Gal A) in an individual with Fabry disease, the method comprising administering subcutaneously or by an oral route or by a parenteral route to the individual a dose of from about 0.1 mg to about 20 mg of α-Gal A per kg. body weight, wherein the dose is administered once per day, once every two days, once every three days, once every four days, once every five days, or once every six days, wherein the parenteral route is selected from the group consisting of the following routes:
- intra-arterial, intraperitoneal, ophthalmic intramuscular, vaginal, intraorbital, intracerebral, intradermal, intracranial, intraspinal, intraventricular, intrathecal, intracisternal, intracapsular, intrapulmonary, intranasal, transmucosal, transdermal and inhalation.
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Dependencies are inferred from the claim text.