CHMP recommends approval of change to marketing terms for Ultomiris for paroxysmal nocturnal haemoglobinuria and atypical haemolytic uremic syndrome.- Alexion Europe
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Ultomiris (ravulizumab) from Alexion Europe SAS.
The CHMP recommended the addition of a new pharmaceutical form (solution for injection in a cartridge) associated with a new strength (245 mg) to be administered subcutaneously via an on-body injector.
The full indications for the new formulation of Ultomiris will be as follows: the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH): in patients with haemolysis with clinical symptom(s) indicative of high disease activity and in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. And for the treatment of adult patients with atypical haemolytic uremic syndrome (aHUS) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.
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