Qalsody

Treatment with Qalsody (tofersen) in the real world slowed disease progression in people with amyotrophic lateral sclerosis (ALS) caused by SOD1 mutations, a small study reports. It also stabilized patients’ quality of life and lowered levels of nerve damage-related biomarkers, which is consistent with clinical trial data that…

Health Canada is now reviewing Qalsody (tofersen) as a potential treatment for people with amyotrophic lateral sclerosis (ALS) who carry mutations in the SOD1 gene, according to the therapy’s developer Biogen. The Canadian regulatory authority agreed to review Biogen’s application for the therapy’s approval, with its decision expected in early 2025, according to…

An advisory committee of the European Medicines Agency (EMA) has recommended that Biogen’s Qalsody (tofersen) be approved in the European Union under exceptional circumstances to treat adults with amyotrophic lateral sclerosis (ALS) associated with SOD1 gene mutations. The positive opinion from the Committee for Medicinal Products for Human Use,…

Throughout 2023, ALS News Today brought you daily coverage of the latest clinical research and scientific breakthroughs related to amyotrophic lateral sclerosis (ALS). Here are the year’s top 10 most-read articles, each with a brief description. We’re excited to remain a dependable resource for the ALS community in…

People with amyotrophic lateral sclerosis (ALS) are not at a higher risk of complications due to a spinal tap than are healthy individuals or those with other neuromuscular disorders, according to a small U.S. study. Findings show that ALS patients have a relatively lower risk for such adverse events,…

The recent conditional approval of Qalsody (tofersen) for adults with amyotrophic lateral sclerosis (ALS) who carry mutations in the SOD1 gene is a major cause for celebration, according to the Muscular Dystrophy Association (MDA). The therapy earned accelerated approval from the U.S. Food and Drug Administration (FDA)…