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).

AstraZeneca’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).

Pascal Soriot

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.

Alexion 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.