Boston, MA 08/25/2014 (wallstreetpr) – Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today that it will be starting clinical trial of eculizumab (Soliris®) in order to evaluate its safety and efficiency. The clinical trial shall be placebo-controlled, single and multinational. This clinical trial shall be carried out for preventing delayed graft function (DGF) among kidney patients.
What is delayed graft function (DGF)?
DGF is found to affect around 25% and as many as 50% deceased-donor kidney transplant cases. This is a serious complication and also early one. DGF is primarily indicative with the failure of transplanted organ, immediately after transplantation. Patients who suffer from DGF need immediate dialysis even after kidney transplant.
Need for Treating DGF Immediately
The clinical trials are meant to address DGF condition as there is an increased medical need to cater to patients suffering from DGF. As of now, no treatment for this condition has been approved yet.
Statement from Alexion Pharmaceuticals
The executive vice president and global head at R&D Department of Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN), Martin Mackay, Ph.D. said that Delayed graft function is a serious complication which arises after successful kidney transplantation. This, he added, is life threatening because of loss of transplanted organ.
Complement activation has a crucial role to play in development of DGF. Martin Mackay also said that because of shortage of donor organs, it becomes important to reduce the risk of DGF so as to also bring down the waiting time for receiving transplant.
Eculizumab (Soliris®) Approval Status
Soliris, at present, has been approved in around 50 countries for paroxysmal nocturnal hemoglobinuria (PNH) patients. Also, 40 countries have approved Soliris for atypical hemolytic uremic syndrome (aHUS) treatment along with two ultra-rare, debilitating and critically fatal disorders which can be caused because of chronic uncontrolled complement activation. However, it is important to note, no country in the world, as yet given its approval to Soliris for preventing DGF after kidney transplant. Approval of Soliris will therefore be a great achievement for the company.
