Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 33 n° 335

ULTOMIRIS® (ravulizumab) Receives Marketing Authorization from European Commission for Adults with Paroxysmal Nocturnal Hemoglobinuria

Posted by fidest press agency su venerdì, 5 luglio 2019

Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the European Commission has approved ULTOMIRIS® (ravulizumab) — the first and only long-acting C5 complement inhibitor administered every eight weeks — for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) with hemolysis with clinical symptoms indicative of high disease activity, and also for adult patients who are clinically stable after having been treated with SOLIRIS® (eculizumab) for at least the past six months.1
PNH is an ultra-rare and severe disease that, when left untreated, may cause a wide range of debilitating symptoms and complications, including thrombosis. Thrombosis occurs when a blood clot presents inside a blood vessel and slows or blocks the flow of blood through the circulatory system. Serious cases of thrombosis can occur throughout the body and result in organ damage, stroke, heart attack, and potentially premature death.2-9
PNH can strike men and women of all races, backgrounds and ages without warning, with an average age of onset in the early 30s.3,10 PNH often goes unrecognized, with delays in diagnosis ranging from one to more than five years.
The European Commission approval is based on comprehensive results from two Phase 3 studies, which were recently published in Blood and represent the largest Phase 3 program ever conducted in PNH.1,12,13 In these studies, which included more than 440 patients who had either never been treated with a complement inhibitor before,14 or who had been stable on SOLIRIS,15 the efficacy of ULTOMIRIS administered every eight weeks was non-inferior to the efficacy of SOLIRIS administered every two weeks on all 11 primary and secondary endpoints. The safety profile of ULTOMIRIS was similar to that of SOLIRIS. Additional data showed that ULTOMIRIS provided immediate and complete C5 inhibition that was sustained for eight weeks between doses,14 and that ULTOMIRIS eliminated breakthrough hemolysis associated with incomplete C5 inhibition.15 The entire clinical development program for ULTOMIRIS in PNH to date represents more than 800 patient years of experience.

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