EMA positive opinion on Orphan Drug Designation to SNF472 for treatment of calciphylaxis
Sanifits lead product SNF472 (intravenous formulation of hexasodium phytate) received a positive opinion for Orphan Drug Designation from the EMA Committee for Orphan Medicinal Products (COMP) for the treatment of Calciphylaxis.
Calciphylaxis or CUA is a rare but dramatic calcification disorder affecting mainly patients with chronic kidney disease. Patients suffer from severe pain, difficult to treat skin lesions and soft tissue calcification. The disease is severely life threatening, often leading to premature death within one year. There is no approved treatment for this condition.
Sanifit will file for orphan designation in the US and other regions. Multinational clinical trials in Calciphylaxis are planned to commence 2013.