Bradley Campbell, President and Chief Operating Officer, and Chip Baird, Chief Financial Officer, will present a corporate overview and fireside chat at the Baird 2018 Global Healthcare Conference on Wednesday, September 5, 2018at 9:40 a.m. E.T.
John F. Crowley, Chairman and Chief Executive Officer, will present a corporate overview and fireside chat at the Bank of America Merrill Lynch Global Healthcare Conferencein London, UKon Wednesday, September 12, 2018at 11:25 a.m. UTC( 7:25 a.m. ET)
A live webcast of both presentations can be accessed through the Investors section of the
INDICATIONS AND USAGE
Galafold is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.
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
The most common adverse reactions reported with Galafold (≥10%) were headache, nasopharyngitis, urinary tract infection, nausea and pyrexia.
USE IN SPECIFIC POPULATIONS
There is insufficient clinical data on Galafold use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Advise women of the potential risk to a fetus.
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
For additional information about Galafold, including the full U.S. Prescribing Information, please visit https://www.amicusrx.com/pi/galafold.pdf.
Associate Director, Investor Relations
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Source: Amicus Therapeutics, Inc.