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Amicus reveals commercial launch of Galafold in Italy for the Fabry community.

M2 EQUITYBITES-March 9, 2017-Amicus reveals commercial launch of Galafold in Italy for the Fabry community

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Biotechnology company Amicus Therapeutics (NasdaqGM:FOLD) reported on Wednesday the commercial availability of the precision medicine Galafold in Italy for Fabry disease.

The company said the launch of Galafold followed the final publication of reimbursement guidelines by the Ministry of Health (Ministero della Salute) in Italy.

Galafold is now reimbursed in Italy as a therapy for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation, added the company.

Fabry disease is reportedly an inherited lysosomal storage disorder caused by deficiency of an enzyme called alpha-galactosidase A (alpha-Gal A), which is the result of mutations in the GLA gene. Galafold is designed to restore alpha-Gal A activity in patients who have amenable mutations.

According to the company, Galafold (migalastat) is a first-in-class chaperone therapy approved in the EU as a monotherapy for Fabry disease in patients with amenable mutations. Galafold works by stabilizing the body's own dysfunctional enzyme, so it can clear the accumulation of disease substrate in patients who have amenable mutations, said the company.

In conjunction, a proprietary in vitro assay (Galafold Amenability Assay) was used to classify more than 800 known GLA mutations as "amenable" or "not amenable" to treatment with Galafold. The current EU label includes 313 GLA mutations that have been identified and determined to be amenable based on the Galafold Amenability Assay. The company expects to submit updates to the label as additional GLA mutations are identified and tested in the Galafold Amenability Assay.

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Publication:M2 EquityBites (EQB)
Date:Mar 9, 2017
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