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Methods Of Treating Fabry Patients Having Renal Impairment

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Summary

USPTO published patent application US20260097027A1 by Amicus Therapeutics Inc. covering methods of treating Fabry disease in patients with renal impairment. The application claims administering migalastat hydrochloride at about 150 mg every other day to patients with HEK assay amenable mutations in α-galactosidase A.

What changed

USPTO published patent application US20260097027A1 disclosing methods for treating Fabry disease patients with renal impairment using migalastat. The application covers administration of about 150 mg migalastat hydrochloride every other day to patients harboring HEK assay amenable mutations in α-galactosidase A.

Pharmaceutical companies developing Fabry disease treatments or generic migalastat formulations should monitor this application. If granted, the patent could create exclusivity for specific dosing regimens in renally impaired populations. Competitors may need to design around these claims or challenge validity during prosecution.

What to do next

  1. Monitor for patent grant or office action responses

Archived snapshot

Apr 10, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← USPTO Patent Applications

Methods Of Treating Fabry Patients Having Renal Impairment

Application US20260097027A1 Kind: A1 Apr 09, 2026

Assignee

Amicus Therapeutics, Inc.

Inventors

Jeff Castelli, Elfrida Benjamin

Abstract

Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.

CPC Classifications

A61K 31/445 A61P 13/12 A61K 9/48

Filing Date

2025-04-21

Application No.

19184366

View original document →

Named provisions

Methods of treating Fabry patients with renal impairment using migalastat

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Last updated

Classification

Agency
USPTO
Published
April 21st, 2025
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
US20260097027A1
Docket
19184366

Who this affects

Applies to
Pharmaceutical companies Drug manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Patent filing Drug development
Geographic scope
United States US

Taxonomy

Primary area
Intellectual Property
Operational domain
Legal
Topics
Pharmaceuticals Public Health

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