Amicus Therapeutics (FOLD) Will Present Data from Fabry Program at Upcoming Conference
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Amicus Therapeutics (Nasdaq: FOLD) announced that 7 posters highlighting its Fabry program will be included in the Society for the Study of Inborn Errors of Metabolism’s 2016 SSIEM Annual Symposium to be held September 6-9, 2016 in Rome, Italy.
Poster Sessions: Wednesday, September 7, 2016 from 6-8pm CEST
- Efficacy and safety of migalastat, an oral pharmacological chaperone for Fabry disease: results from two randomized Phase 3 studies – Prof Roberto Giugliani, Medical Genetics Service, Clinic Hospital of Porto Alegre, Porto Alegre, Brazil (P-540)
- Comparison of α-galactosidase A activity in white blood cells of patients with Fabry disease after 2 weeks of exposure to migalastat, agalsidase beta, or agalsidase alfa -- Franklin Johnson, MS, Amicus Therapeutics, Inc, Cranbury, USA (P-543)
- Phenotype of Fabry disease in patients with mutations amenable to migalastat - Derralynn Hughes, DPhil, University College, London, UK (P-549)
- Efficacy of migalastat in the cohort of male patients with classic disease presentation of Fabry disease in a Phase 3 study - Prof DP Germain, Division of Medical Genetics, University of Versailles, Paris-Saclay University, Versailles, and Assistance Publique–Hopitaux de Paris, Paris, France (P-546)
- Migalastat improves gastrointestinal symptoms in patients with Fabry disease: results from a double-blind, placebo-controlled phase 3 trial (FACETS) – Dr. Schiffmann, Institute of Metabolic Disease, Baylor Research Institute, Dallas, USA (P-541)
- The validation of pharmacogenetics in the identification of patients with Fabry disease for treatment with migalastat – Xiaoyang Wu, PhD, Amicus Therapeutics, Inc. Cranbury, USA (P-547)
- Estimating the value of treatment for Fabry disease: a discrete choice experiment - Alasdair MacCulloch, BSc PG(cert) H Econ PhD, Amicus Therapeutics UK Limited., London, UK (P-531)
Amicus will also be sponsoring a satellite symposium on September 7, 2016 from 7-8:30pm CEST titled “Chaperone Therapy: Escorting Fabry Disease into a New Era,” bringing leading international experts together to explore the complexity of Fabry disease and examine how an in-depth understanding of the molecular mechanisms of the disease has resulted in the development of a new, targeted treatment approach for the management of adult and adolescent patients with amenable mutations.
Important Safety InformationTreatment with GALAFOLD should be initiated and supervised by specialists experienced in the diagnosis and treatment of Fabry disease. GALAFOLD is not recommended for use in patients with a nonamenable mutation.
- GALAFOLD is not intended for concomitant use with enzyme replacement therapy.
- GALAFOLD is not recommended for use in patients with Fabry disease who have severe renal impairment (<30 mL/min/1.73 m2). The safety and efficacy of GALAFOLD in children 0–15 years of age have not yet been established.
- No dosage adjustments are required in patients with hepatic impairment or in the elderly population.
- There is very limited experience with the use of this medicine in pregnant women. If you are pregnant, think you may be pregnant, or are planning to have a baby, do not take this medicine until you have checked with your doctor, pharmacist, or nurse.
- While taking GALAFOLD, effective birth control should be used. It is not known whether GALAFOLD is excreted in human milk.
- Contraindications to GALAFOLD include hypersensitivity to the active substance or to any of the excipients listed in the PRESCRIBING INFORMATION.
- It is advised to periodically monitor renal function, echocardiographic parameters and biochemical markers (every 6 months) in patients initiated on GALAFOLD or switched to GALAFOLD.
- OVERDOSE: General medical care is recommended in the case of GALAFOLD overdose.
- The most common adverse reaction reported was headache, which was experienced by approximately 10% of patients who received GALAFOLD. For a complete list of adverse reactions, please review the SUMMARY OF PRODUCT CHARACTERISTICS.
- Call your doctor for medical advice about side effects.
For further important safety information for Galafold, including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European SmPC for Galafold available from the EMA website at www.ema.europa.eu.
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