Alexion Pharmaceuticals said it has won an orphan-drug designation from the U.S. Food and Drug Administration for its commercial drug Soliris.
Orphan drug designations are meant to incentivize pharmaceutical companies to design drugs for rare diseases and disorders that have unmet treatment needs.
The designation incentivizes Alexion to pursue a clinical trial so it can expand the use of its drug, which is already approved for patients with rare blood disorders.
The new designation covers a complication known as delayed graft function, which can cause transplanted organs to function improperly in renal transplant patients. Patients who develop DGF need dialysis to survive, according to Alexion.
If the designation leads to regulatory approval, Soliris will receive seven years of marketing exclusivity as well as a tax credit worth half of its clinical investigation expenses.
The company is planning a multinational DGF registration study with Soliris later this year.
