Alexion Completes Enrollment of Its Pivotal Phase III TRIUMPH Trial

Alexion Pharmaceuticals has completed enrollment of the pivotal Phase III TRIUMPH efficacy trial of eculizumab in patients with the chronic orphan blood disorder Paroxysmal Nocturnal Hemoglobinuria (PNH).

In accordance with the trial's design, enrolled patients first enter a screening phase of up to three months to confirm their eligibility to be randomized, and are then randomized to receive either eculizumab or placebo in the six-month treatment phase. More than 75 PNH patients have already been randomized into the six-month treatment phase, which exceeds both the company's goal ahead of schedule and the patient requirements of the TRIUMPH special protocol assessment agreed to with the FDA last year.

Having completed enrollment, it is anticipated that the final patient will be randomized prior to the end of June and complete the six-month treatment phase by year end.