The European Commission designates Alexion Pharmaceuticals' (ALXN) Soliris (eculizumab) an orphan drug for the prevention of graft rejection following solid organ transplantation.
Soliris is currently approved in the U.S., European Union, Japan and other countries for the treatment of paroxysmal nocturnal hemoglobinuria and atypical uremic syndrome.
The company is currently investigating the product's use for the prevention of acute antibody-mediated rejection in kidney transplants and for the prevention of delayed graft function in patients receiving deceased donor kidney transplants.
The EC's orphan drug designation applies to medical products that treat, prevent or diagnose diseases or conditions that affect no more than five in 10,000 people. Like the U.S., the product will have a period of market exclusivity in the EU upon regulatory approval for the specific indication.