AstraZeneca’s Alexion received a supplemental New Drug Application approval for Ultomiris (ravulizumab-cwvz) from the U.S. Food and Drug Administration to treat adults with generalized myasthenia gravis (gMG).
Alexion Settles Patent Infringement Lawsuits Against Ultomiris for $775 Million
Alexion, AstraZeneca, Atypical Hemolytic Uremic Syndrome (aHUS), Business, C5 Complement Inhibitors, Chugai Pharmaceutical, Lawsuits, Paroxysmal Nocturnal Hemoglobinuria (PNH), Patent Disputes, Patent Infringement, Patents, TherapeuticsAstraZeneca’s rare disease arm Alexion agreed to resolve all patent disputes with Chugai Pharmaceutical regarding the prescription drug Ultomiris (ravulizumab) by signing a settlement agreement that will involve a one-time payment of $775 million.
Alexion, the unit within global pharmaceutical firm AstraZeneca that focuses on finding treatments for rare diseases, is halting clinical trials for Ultomiris (ravulizumab) for adults with amyotrophic lateral sclerosis.
Boston-based Alexion Pharmaceuticals announced positive topline data from the company’s Phase III trial of Ultomiris (ravulizumab-cwvz) in adults with generalized myasthenia gravis.
The U.S. Food and Drug Administration approved the expanded use of Alexion Pharmaceuticals Inc.’s Ultomiris (ravulizumab-cwvz) to include children (1 month of age and older) and adolescents with paroxysmal nocturnal hemoglobinuria (PNH).
AstraZeneca is acquiring Alexion Pharmaceuticals for $39 billion, with the deal expected to close in the third quarter of 2021.
The U.S. Food and Drug Administration approved Alexion Pharmaceuticals Inc.’s Ultomiris for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy for adult and pediatric patients.
FDA Accepts Priority Review Of ALXN1210 As Treatment For Patients With Paroxysmal Nocturnal Hemoglobinuria
Blood Disorders, C5 Complement Inhibitors, Clinical Data, Clinical Trials, FDA/Regulatory, Immune System, Orphan Drug Designation, Paroxysmal Nocturnal Hemoglobinuria (PNH), Paroxysmal Nocturnal Hemoglobinuria (PNH), PDUFA, Priority ReviewAlexion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration accepted for review the company’s Biologics License Application for approval of ALXN1210, an investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria.