A RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF AT1001 AND ENZYME REPLACEMENT THERAPY (ERT) IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS, WHO WERE PREVIOUSLY TREATED WITH ERT
Phase of Trial: Phase III
Latest Information Update: 15 Aug 2017
At a glance
- Drugs Migalastat (Primary) ; Enzyme replacements
- Indications Fabry's disease
- Focus Registrational; Therapeutic Use
- Acronyms ATTRACT
- Sponsors Amicus Therapeutics
- 15 Aug 2017 According to an Amicus Therapeutics media release, the Australian Therapeutic Goods Administration (TGA) has approved Galafold (migalastat) for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation, based on data from FACETS, ATTRACT and extension study .
- 11 Jul 2017 According to an Amicus Therapeutics media release, the company plans to submit a new drug application (NDA) to the U.S. FDA for migalastat for Fabry disease in the fourth quarter of 2017. Based on a series of discussions with and written communication received from the FDA, the Agency has informed Amicus that it may now submit an NDA for migalastat.
- 11 Jul 2017 According to an Amicus Therapeutics media release, the company is preparing the NDA submission under Subpart H, which provides for accelerated approval. Amicus intends to base its NDA on existing data, including reduction in disease-causing substrate (GL-3), as well as the totality of data from completed clinical studies.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History