European Union gives approval to Alexion’s Ultomiris for PNH in Adults

An announcement was made by the Alexion Pharmaceuticals that Ultomiris, its long-acting c5 complement inhibitor has been approved by the European Commission.

EU gave approval of the drug for the treatment of patients with paroxysmal nocturnal hemoglobinuria with hemolysis, with clinical symptoms revealing high disease activity. The drug also got approval for adult patients who are clinically stable after getting treated with the lead drug of Alexion, Soliris, for at least the past 6 months.

European Union gave approval based on the comprehensive results from two phase 3 studies, which included over 440 patients who had either been stable on Soliris or were never been treated with a complement inhibitor.

Data from the studies reflected that the effectiveness of Ultomiris administered every 8 weeks was non-inferior to the effectiveness of Soliris administered every 2 weeks at all eleven primary, as well as, secondary endpoints.

Further data showed that Ultomiris provided instant & complete C5 inhibition which was sustained for 8 weeks between doses. The drug eradicated breakthrough hemolysis linked with incomplete C5 inhibition.

In addition to this, the patients could easily transition to Ultomiris from Soliris.

The approval of the drug will reinforce Alexion’s paroxysmal nocturnal hemoglobinuria franchise, as Soliris is already approved for the same. The drug is already approved in the US for this indication. Early conversion rates of Soliris patients have been promising. Most recently, the drug has gotten approval in Japan.

The share price of the Alexion has rallied 36.9 percent year till present compared with the industry’s growth of 7.1 percent.

The approval of the drug, Ultomiris, has enhanced growth prospects considerably for the firm. In addition to this, the firm is working to advance the drug’s label. The Food & Drug Administration recently accepted Alexion’s supplemental biologics license application for Ultomiris.