Amicus Therapeutics to Highlight Fabry Disease Program at the 13th International Congress of Inborn Errors of Metabolism (ICIEM)
Poster Sessions:
- Long-Term Migalastat Treatment Stabilizes Renal Function in Patients With Fabry Disease: Results From a Phase 3 Clinical Study (AT1001-041) - Prof
Charles Lourenco , MD,University of Sao Paulo, Brazil (P-638)
- Effects of Treatment With Migalastat on the Combined Endpoint of Kidney Globotriaosylcermide Accumulation and Diarrhea in Patients With Fabry Disease: Results From the Phase 3 FACETS Study -
Raphael Schiffmann , MD,Institute of Metabolic Disease ,Baylor Research Institute ,Dallas, TX (P-645)
- Efficacy and Safety of Migalastat, an Oral Pharmacological Chaperone for Fabry Disease: Renal Findings From Two Randomized Phase 3 Studies (FACETS and ATTRACT) -
Ana Jovanovic , MD,Salford Royal Hospital andNHS Foundation Trust ,Manchester, UK (P-636)
- Response of Patients With Fabry Disease With the Amenable GLA Mutation p.N215S to Treatment With Migalastat - Prof
Ulla Feldt-Rasmussen , MD, PhD,Department of Medical Endocrinology ,Rigshospitalet Copenhagen University Hospital ,Copenhagen, Denmark (P-644)
- Improvements in Cardiac Mass and Function With Long-Term Migalastat Treatment in Patients With Fabry Disease:
Results From Phase 3 Trials -
Ana Jovanovic , MD,Salford Royal Hospital andNHS Foundation Trust ,Manchester, UK (P-2667)
- A Next-Generation Fabry Enzyme Replacement Therapy: Co-formulation of a Proprietary Recombinant Human α-Galactosidase A With a Pharmacological Chaperone Has Greater Efficacy Than Agalsidase β in Mice -
Su Xu , PhD,Amicus Therapeutics, Inc. Cranbury, USA (P-2576)
Important Safety Information
Treatment 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.
About
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to preclinical and clinical development of our product candidates, The inclusion of forward-looking statements should not be regarded as a representation by us that any of our plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong and can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. For example, with respect to statements regarding clinical trials, actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business, including, without limitation: the potential that results of
clinical or preclinical studies indicate that the product candidates are unsafe or ineffective; the potential that it may be difficult to enroll patients in our clinical trials; the potential that regulatory authorities, including the
FOLD-G
CONTACTS: Investors/Media:Source:Amicus Therapeutics Sara Pellegrino , IRC Senior Director, Investor Relations spellegrino@amicusrx.com (609) 662-5044 Media:W2O Group Brian Reid breid@w2ogroup.com (212) 257-6725
News Provided by Acquire Media