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Soliris Effective in PNH Patients With History of Aplastic Anemia,and Myelodysplastic Syndromes

undergoing therapy with Soliris (p<0.001). Patients with a history of AA or MDS also reported a noticeable improvement in fatigue and overall quality-of- life, similar to the clinical improvements reported by the overall PNH patient population in the TRIUMPH and SHEPHERD studies. Patients with a history of AA or MDS had an elevated rate of thromboembolic events prior to entering the studies (11.13 events per 100 patient-years; n=59) and the rate with Soliris treatment was 1.04 events per 100 patient-years (P<0.001). Soliris appeared to be safe and well-tolerated when administered to PNH patients with a history of AA or MDS, similar to results in the overall population in the TRIUMPH and SHEPHERD studies.(8)

About PNH

PNH is an acquired genetic blood disorder defined by hemolysis, in which patients' red blood cells are destroyed by complement, a component of the body's immune system. PNH affects an estimated 8,000 to 10,000 people in North America and Europe.(9) PNH often strikes people in the prime of their lives, with an average age of onset in the early 30's.(10) Ten percent of all patients first develop symptoms at 21 years of age or younger.(2) PNH develops without warning and can occur in men and women of all races, backgrounds and ages. PNH often goes unrecognized, with delays in diagnosis often ranging from one to more than 10 years.(7) The estimated median survival for PNH patients is between 10 and 15 years from the time of diagnosis.(5)(11)

About Soliris

Soliris is the first therapy approved by the U.S. Food and Drug Administration for the treatment of PNH. Soliris is indicated for the treatment of patients with PNH to reduce hemolysis. In April the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMEA) adopted a positive opinion recommending marketing authorization for Soliris for the treatment of all patients with PNH. Final EU approval is expected in June or July 2007.

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