Alexion’s sBLA for Soliris receives FDA Concern Review designation to treat aHUS Alexion Pharmaceuticals, Inc SilagraCipla.net . announced today that the U.S. A Priority Review designation is given to drugs that may give major improvements in treatment, or give a treatment where no sufficient therapy exists. If acceptance can be granted, Alexion anticipates that Soliris would be designed for U.S. Individuals with aHUS in the fourth one fourth of 2011. The European Medicines Agency is also reviewing a marketing application for Soliris as a treatment for patients with aHUS in europe. Both US and EU sBLA submissions include the positive data from both 26-week Phase 2 research of Soliris as a treatment for adult and adolescent patients with aHUS.
Water allows much easier conduction of the shock waves through the patient’s tissue and specific concentrate on the kidney rock. ‘This is a completely new getting,’ says Amy Krambeck, M.D., Mayo Clinic urology resident and lead study investigator. ‘This opens the eye of the world of urology to the fact that hypertension and diabetes are potential unwanted effects. We can’t say with 100 % certainty that the shock wave treatment for the kidney stones triggered diabetes and hypertension, however the association was quite strong. The risk of developing diabetes after shock wave lithotripsy is nearly four times the chance of people with kidney stones treated with medicine, and the risk of developing hypertension is normally one and one-half moments, which is a significant risk increase.’ The scholarly study, which may be the first exam of the consequences of shock wave lithotripsy over the future, included reviewing charts of 630 individuals treated with shock wave lithotripsy in 1985 at Mayo Clinic.