Category: Approval/Launch Region: North America · United States Company: Biogen Us Corporation

Us Fda Grants Accelerated Approval For Qalsody To Treat Als In Adults Who Have A Mutation In Sod1 Gene

Us Fda Grants Accelerated Approval For Qalsody To Treat Als In Adults Who Have A Mutation In Sod1 Gene
Biogen Inc., A Leading Global Biotechnology Company, Announced That The Us Food And Drug Administration (Fda) Has Approved Qalsody (Tofersen) 100 Mg/15Ml Injection For The Treatment Of Amyotrophic Lateral Sclerosis (Als) In Adults Who Have A Mutation In The Superoxide Dismutase 1 (Sod1) Gene. This Indication Is Approved Under Accelerated Approval Based On Reduction In Plasma Neurofilament Light Chain (Nfl) Observed In Patients Treated With Qalsody. Continued Approval For This Indication May Be Contingent Upon Verification Of Clinical Benefit In Confirmatory Trial(S). The Ongoing Phase 3 Atlas Study Of Tofersen In People With Presymptomatic Sod1-Als Will Serve As The Confirmatory Trial.Neurofilaments Are Proteins That Are Released From Neurons When They Are Damaged, Making Them A Marker Of Neurodegeneration.

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