Amicus Therapeutics. has been granted a patent for dosing regimens using migalastat to treat Fabry disease. The methods target both ERT-experienced and ERT-naïve patients, focusing on improving left ventricular mass and reducing gastrointestinal symptoms, specifically in patients with certain a-Galactosidase A mutations. GlobalData’s report on Amicus Therapeutics gives a 360-degree view of the company including its patenting strategy. Buy the report here.
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According to GlobalData’s company profile on Amicus Therapeutics, Human telomerase RT biomarker was a key innovation area identified from patents. Amicus Therapeutics's grant share as of July 2024 was 41%. Grant share is based on the ratio of number of grants to total number of patents.
Migalastat dosing regimens for treating fabry disease symptoms
The granted patent US12070453B2 outlines a method for alleviating gastrointestinal symptoms in patients with Fabry disease, specifically targeting those who are enzyme replacement therapy (ERT)-naïve. The method involves administering migalastat or its salt in an effective dosage of approximately 123 mg free base equivalent (FBE) every other day. The gastrointestinal symptoms addressed include diarrhea, reflux, and indigestion, particularly in patients with specific mutations in the a-Galactosidase A gene, such as A156T, D33G, G144V, and M187I. The claims emphasize that treatment for a duration of at least 6 to 18 months can lead to significant reductions in these symptoms, as measured by the Gastrointestinal-Symptoms-Rating-Scale (GSRS).
Further claims detail the formulation's oral dosage forms, which may include tablets, capsules, or solutions. The patent specifies that the administration of migalastat not only targets diarrhea but also aims to reduce reflux and indigestion, with quantifiable improvements noted in the GSRS assessments. The method is particularly relevant for patients exhibiting baseline gastrointestinal symptoms, providing a structured approach to managing these conditions in the context of Fabry disease. The patent thus presents a targeted therapeutic strategy for a specific patient demographic, focusing on both symptom relief and the underlying genetic factors associated with the disease.
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GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies
