News

Canadian Agency Urges Reimbursement for Galafold to Treat Fabry Disease

The Canadian Drug Expert Committee (CDEC) has recommended in favor or reimbursement of Galafold (migalastat) for long-term treatment of adults with a confirmed diagnosis of Fabry disease and who have an amenable mutation, Amicus Therapeutics announced. CDEC will now start conversations with regulatory authorities to make Galafold available to Canadian…

European Regulators Grant Orphan Drug Status to Protalix’s PRX-102 for Fabry Disease

The European Commission has granted Protalix BioTherapeutics’ experimental treatment PRX-102 (pegunigalsidase alfa) Orphan Drug Designation for the treatment of Fabry disease, the company recently announced. The decision follows a European Medicines Agency (EMA) recommendation in November 2017, which stated the therapy may be of “significant benefit” to Fabry…