17 April 2019 - Italy’s Recordati said on Tuesday it plans to seek Canadian approval for its drug Cystagon, which treats a rare kidney disease, in a potential blow to Horizon Pharmaceuticals, which makes the only drug approved for treatment in Canada.

Cystagon and Horizon’s drug Procysbi use the same active ingredient to treat nephropathic cystinosis, a genetic disorder that can cause fatal kidney damage. Only about 100 people in Canada have the disease, but at list prices Procysbi costs C$325,000 ($243,336.33) per year, according to Canadian regulators.

Cystagon, which is manufactured by Mylan Pharmaceuticals and sold in Canada and Europe by Recordati, has been available in Canada for more than two decades under a special program that lets patients use drugs not approved in the country as long as there is no alternative available.

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