FDA accepts biologics license application for PNH in research drug ALXN1210

recently, Alexion Pharmaceuticalsthat the FDA,, has accept
ed an application for a biological license (BLA) for theof the drug , the Ravulizumab, for a valiant sleeping hemoglobinuria (PNH)also based on the company's use of the Rare Disease Priority Review Voucher, the FDA has given the PDUFA date february 18, 2019, which will be four months ahead of the standard 12-month review timethe research data based on this BLA are the combined data of two clinical phase 3 studiesFor patients with initial treatment of tonic inhibitors, the 8-week ALXN 1210 intravenous treatment showed the non-performance of the intravenous treatment every two weeks with the company Soliris (eculizumab, Ikuzumab),the test(all numerical results supporting the primary and critical secondary endpoints of ALXN1210 were obtained)The Phase 3 clinical development program of ALXN 1210 is the largest clinical Phase 3 trial in PNH's historyThe study recruited more than 440 patients, including those who had never been treated with tonic inhibitors, and patients who had been steadily receiving Soliris to switch to ALXN1210If approved, ALXN 1210 will be the first and only PNH long-acting tonic inhibitor that can provide immediate and complete inhibition of C5 supplement proteins in PNH patients, with a sustainable dose interval of 8 weeksIn addition to submitting listing applications to the United States and Europe, Alexion has plans to submit an application for treatment for PNH patients in Japan in the second half of this year for ALXN 1210