FDA Grants Accelerated Approval For Biogen's ALS Drug

(RTTNews) - Biogen Inc. (BIIB) said that the U.S. Food and Drug Administration has approved Qalsody (tofersen) 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis or ALS in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

The 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.

The company noted that Qalsody will be made available for shipment in the U.S. to healthcare providers in approximately one week. Biogen anticipates there may be variation in time to treatment as institutions and treatment centers learn about Qalsody.

Qalsody is the first approved treatment to target a genetic cause of ALS. Biogen collaborated with Ionis Pharmaceuticals on the early development of tofersen.

Warnings and precautions associated with Qalsody were serious neurologic events, including myelitis and/or radiculitis; papilledema and elevated intracranial pressure; and aseptic meningitis.

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