Biogen’s QALSODY® (tofersen), the First Therapy to Treat Rare, …
Feb 23, 2024 · About QALSODY ® (tofersen) QALSODY ® (tofersen) is an antisense oligonucleotide (ASO) designed to bind to SOD1 mRNA to reduce SOD1 protein production. The U.S. Food and Drug Administration granted accelerated approval for QALSODY to treat amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 …
Biogen’s QALSODY® (tofersen), the First Therapy to Treat Rare, …
Feb 23, 2024 · If authorized by the European Commission (EC), QALSODY will be the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND).
Biogen Receives European Commission Approval for QALSODY® …
May 30, 2024 · QALSODY is the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND).
FDA approves QALSODY™ (tofersen) as the first treatment …
Apr 25, 2023 · QALSODY is the first and only approved treatment to target a genetic cause of ALS and the latest Ionis-discovered medicine to gain market approval. Neurofilaments are proteins that are released...
FDA Approves Biogen’s Drug for Rare Form of ALS - The New York Times
Apr 25, 2023 · The drug, which will be sold as Qalsody by the pharmaceutical company Biogen, targets a genetic cause of a devastating neurological illness.
Private Medicare plans must cover Biogen's ALS drug, US agency …
2 days ago · Qalsody received the U.S. Food and Drug Administration's accelerated approval last year, but CMS said it found many Medicare Advantage plans, which cover adults 65 years and older or those with ...
FDA approves treatment of amyotrophic lateral sclerosis …
FDA approved Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS). Qalsody is an antisense ...
FDA grants accelerated approval for Biogen’s Qalsody to treat ALS
Apr 26, 2023 · The US Food and Drug Administration (FDA) has granted accelerated approval for Biogen’s Qalsody (tofersen) 100mg/15mL injection to treat adult amyotrophic lateral sclerosis (ALS) patients with a mutation in the superoxide dismutase 1 (SOD1) gene.
Groundbreaking Directive Ensures ALS Patients on Medicare …
4 days ago · Plans Required to Cover Treatment for SOD1-ALS. December 11, 2024 (Arlington, VA) – The Centers for Medicare & Medicaid Services (CMS) has announced a first-of-its-kind directive requiring Medicare Advantage plans to approve coverage for Qalsody, a treatment for people living with genetic SOD1-ALS.This decision reflects the ALS Association’s commitment to ensuring that people living with ...
Groundbreaking Directive Ensures ALS Patients on Medicare …
3 days ago · In the phase 3 VALOR trial, Qalsody reduced levels of mutated SOD1 proteins in cerebral spinal fluid by 35% within eight weeks and decreased bloodstream levels of neurofilament light chain (NfL ...