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Amicus Therapeutics Awarded United Kingdom Prix Galien Medal for Galafold® (Migalastat) | ||
By: Nasdaq / GlobeNewswire - 11 Dec 2018 | Back to overview list |
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First Orphan Drug to Win Prestigious “Innovative Product” Award CRANBURY, N.J. and LONDON, Dec. 11, 2018 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), a global biotechnology company focused on discovering, developing and delivering novel medicines for rare metabolic diseases, today announced that Galafold® (migalastat) was awarded the 2018 UK Prix Galien Medal for Innovative Product. The Prix Galien is awarded to companies who have made significant advances in pharmaceutical research, and is regarded as the highest accolade for biomedical research and development. John F. Crowley, Chairman and Chief Exeutive Officer of Amicus Therapeutics, Inc., stated, “We are honored to receive the prestigious UK Prix Galien medal for Galafold, the first ever orphan drug to win in the Innovative Product category. We believe that this award embodies the efforts among our team at Amicus, together with patients, physicians and the broader Fabry community, to globally develop and deliver Galafold as a medicine for certain individuals who are diagnosed with Fabry disease and who have an amenable GLA mutation, or variant. The Prix Galien awards are considered by many to be the industry’s equivalent of a Nobel Prize, and we are grateful to the Galien Foundation for this very important recognition.” “The 2018 Awards yet again confirmed the depth and diversity of innovation in UK life sciences. The success of products for rare disease – which, for the first time, dominated the shortlist of finalists – shows that innovation is not confined to Big Pharma or treatments for major headline conditions," said Karen Westaway, Chief Executive of ValueBase, owners of Prix Galien’s UK franchise. Galafold is approved in the European Union (EU), U.S., Australia, Canada, Israel, Japan, South Korea and Switzerland. About Prix Galien About Galafold® U.S. INDICATIONS AND USAGE This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. U.S. IMPORTANT SAFETY INFORMATION ADVERSE REACTIONS USE IN SPECIFIC POPULATIONS It is not known if Galafold is present in human milk. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Galafold and any potential adverse effects on the breastfed child from Galafold or from the underlying maternal condition. Galafold is not recommended for use in patients with severe renal impairment or end-stage renal disease requiring dialysis. The safety and effectiveness of Galafold have not been established in pediatric patients. To report Suspected Adverse Reactions, contact Amicus Therapeutics at 1-877-4AMICUS or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For additional information about Galafold, including the full U.S. Prescribing Information, please visit https://www.amicusrx.com/pi/galafold.pdf. About Fabry Disease About Amicus Therapeutics Forward-Looking Statements NP-GA-ALL-00021218 CONTACTS: Investors/Media: Media: FOLD–G |
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Copyright 2018 Nasdaq / GlobeNewswire | Back to overview list |