ARTICLE | Regulation
Nov. 20 Quick Takes: Approvals in Europe for Alnylam, Alexion therapies; plus FDA priority review for ADC, Sanofi and more
November 21, 2020 12:26 AM UTC
EC approves Alnylam, Alexion therapies
Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) said the European Commission approved Oxlumo lumasiran, an RNAi therapy targeting the HAO1 mRNA that encodes glycolate oxidase, to treat primary hyperoxaluria in all age groups.
The EC also approved a 100 mg/mL IV formulation of Ultomiris ravulizumab from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) to treat two ultra-rare diseases, paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. The new formulation will reduce annual infusion times by 60% compared with the 10 mg/mL version. ...