Shots: The approval is based on P-III head-to-head PEGASUS study assessing Empaveli vs Soliris (eculizumab) in 80 adults with PNH. Participants should be Soliris stable for at least 3mos. with […]readmore
Tags : Paroxysmal Nocturnal Hemoglobinuria
Shots: The P-II study involves assessing of LNP023 in PNH patients with active hemolysis despite treatment with eculizumab Results: improvements in hematological response and biomarkers of disease activity; 70% discontinued […]readmore
Regulatory
Achillion’s Danicopan (ACH-4471) Receives FDA’s Breakthrough Therapy Designation for Paroxysmal
Shots: The FDA’s BT designation is based on safety & efficacy data of ongoing P-II study assessing Danicopan in combination with C5 mAb for patients with paroxysmal nocturnal hemoglobinuria (PNH) […]readmore
Shots: The P-III study involves assessing of SB12(600/900 mg, IV) vs Soliris (eculizumab, 600/900 mg, IV) in 50 patients with PNH, evaluating the efficacy, safety, immunogenicity and PK The primary […]readmore
Biotech
Regulatory
Alexion’s Ultomiris (Ravulizumab) Receives European Commission’s Marketing Authorization for Paroxysmal
Shots: The approval is based on two P-III studies assessing Ultomiris (q8w) in 440+ patients with PNH prior not treated with complement inhibitor or treated with Soliris (eculizumab, q2w) for […]readmore
Regulatory
Alexion’s Ultomiris (ravulizumab) Receives MHLW’s Marketing Authorization to Treat Paroxysmal
Shots: The approval is based on two P-III studies results assessing Ultomiris (IV, q8w) in 441 patients with PNH with no prior treatment with complement inhibitor or who had been […]readmore
Biosimilars
Biotech
Generium and Selexis Launch Eculizumab Biosimilar for Paroxysmal Nocturnal Hemoglobinuria
Shots: Generium’s biosimilar of Eculizumab is developed using Selexis’ SUREtechnology Platform which is based on Selexis SGE (Selexis Genetic Elements) consist of human DNA based element, controlling the chromatin across […]readmore