Earlier today, Amicus Therapeutics announced it has initiated the commercial launch of the oral small molecule pharmacological chaperone Galafold capsules 123mg for treatment of patients aged 16 years and older with a confirmed diagnosis of Fabry disease and who have an amenable mutation. Galafold is the first and only oral precision medicine for Fabry disease in Japan. John F. Crowley, Chairman and CEO of Amicus Therapeutics, Inc., stated, “The launch of Galafold in Japan, less than one year after our J-NDA submission, provides a significant opportunity for us to deliver this oral and differentiated precision medicine to amenable Fabry patients living in Japan. This is the result of Amicus employees, Japanese regulators, and the Fabry community working together to advance Galafold, in particular those physicians and patients who participated in the clinical studies of Galafold and their families. An estimated 850 people are currently known to be living with Fabry disease in Japan. We believe a significant portion of these Fabry patients have amenable mutations that could benefit from treatment with Galafold. Introducing Galafold in Japan is very important to our patient-focused vision to provide Galafold to Fabry patients with amenable mutations throughout the world as soon as possible. We also hope to have many future opportunities to deliver new medicines for people living with rare metabolic diseases in Japan.” Shares of Amicus are up 7.17% or $1.12 to $16.85 per share in early afternoon trading.
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