Alexion gets positive CHMP opinion on extended indication for eculizumab The EMA's Committee for Medicinal Products for Human Use adopted a positive opinion recommending a variation to the terms of the marketing authorization for the medicinal product Soliris. The marketing authorization holder for this medicinal product is Alexion Europe SAS. Soliris is currently authorized for the treatment of paroxysmal nocturnal haemoglobinuria in adults only and atypical haemolytic uremic syndrome in adults and children. The CHMPís opinion now recommends that the PNH indication be extended to include children, the EMA announced.
Alexion announces $500M share repurchase program Alexion Pharmaceuticals announced that the companyís board has authorized a new share repurchase program of up to $500M. The new share repurchase program will take effect upon completion of the companyís current program, which has approximately $22M remaining of its previously authorized $400M.