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Article Excerpt
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN), Cheshire, Conn., has received written confirmation from the U.S. Food and Drug Administration (FDA) indicating agreement with the two protocols constituting the pivotal Phase III program of its investigational drug eculizumab for the chronic orphan blood disorder Paroxysmal Nocturnal Hemoglobinuria (PNH). The Phase III program includes the TRIUMPH pivotal trial
together with a companion safety trial called SHEPHERD. The agreement for the Phase III program was reached under the FDA's Special Protocol Assessment (SPA) process, a procedure by which the FDA provides official evaluation and guidance on proposed protocols for pivotal Phase III clinical trials. It is expected that, if successful, the trials will complete the filing package that will serve as the primary basis of review for the approval of a Biologics License Application for the PNH indication.
The pivotal Phase III trial, called TRIUMPH, will examine the effects of eculizumab on the co-primary endpoints of hemoglobin stabilization and blood transfusion in hemolytic transfusion-dependent...
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