- Alexion Pharmaceutical has begun dosing study subjects with Soliris (eculizumab) in a trial designed to evaluate efficacy and safety endpoints for preventing delayed graft function (DGF) in transplant patients.
- The study subjects are patients who have received kidney transplants from deceased donors. Patients who experience DGF after transplant generally have to go on dialysis, as there are no current treatment options. Up to 50% of deceased-donor kidney transplant cases are affected by DGF.
- Soliris is currently approved in about 50 countries for the treatment of paroxysmal nocturnal hemoglobinuria and 40 countries for treatment of atypical hemolytic uremic syndrome (aHUS).
Eculizumab is being tested in patients at risk of DGF, because complement activation plays a critical role in the development of DGF. According to Alexion executive vice president and global head of R&D, Martin Mackay, “A terminal complement inhibitor like eculizumab may have the potential to prevent this devastating complication.”
In addition to supporting the well-being of an individual patient, being able to prevent DGF may have a broader impact by allowing more deceased-donor organs to be successfully transplanted, resulting in a shorter waiting time to receive a transplant.
Alexion has made its name on the strength of eculizumab, whose sales rose 38% in Q2 2014 to $512.5 million. In fact, the drug has helped Alexion become one of the pharma companies with the highest profit margins, with profits of about $0.43 for every dollar in sales.