FDA Approves sBLA for Soliris in aHUS
Alexion announced that the FDA has approved the supplemental Biological License Application (sBLA) granting regular approval for Soliris (eculizumab) for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).
Soliris, a terminal complement inhibitor, received Accelerated Approval for this indication from the FDA in September 2011. As part of the postmarketing requirements, Alexion has submitted confirmatory data from 2 additional prospective clinical trials, including one in pediatric patients with aHUS.
The revised label now includes longer-term clinical benefit associated with chronic and sustained Soliris treatment with inclusion of results with 2 years of ongoing treatment in patients with aHUS. Results from the 2 additional prospective trials showed that Soliris inhibited systemic complement-mediated TMA (the formation of blood clots in small blood vessels throughout the body), improved renal function, decreased or eliminated the need for dialysis and was well-tolerated. Data on the use of Soliris prior to use of supportive care with either plasma exchange or plasma in prospective clinical trials is also included.
For more information call (888) 765-4747or visit Soliris.net.