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The newly approved drug was shown to slow the progression of symptoms of ALS in a Phase 2 trial.
Tofersen was developed by Ionis Pharmaceuticals and was licensed to, and co-developed by, Biogen. [7] [8]The effectiveness of tofersen was evaluated in a 28-week, randomized, double-blind, placebo-controlled clinical study in 147 participants with weakness attributable to amyotrophic lateral sclerosis and a superoxide dismutase 1 (SOD-1) mutation confirmed by a central laboratory. [2]
The FDA recently approved Relyvrio, a drug to treat ALS, but the agency also concluded that it’s hard to say if it actually works.
The Food and Drug Administration approved the much-debated drug, Relyvrio, in September 2022, following a years-long advocacy campaign by patients with amyotrophic lateral sclerosis, or ALS.
The company had received Orphan Drug Designation for edaravone from the FDA and EU by 2016. [12] It was approved for ALS in the US in 2017, based on a small randomized controlled clinical trial with people who had early-stage ALS in Japan, who were administered the medication for 6 months; it had failed two earlier trials in people with all ...
Health reporter Anjalee Khemlani outlines the circumstances behind the FDA's approval of a new ALS treatment drug amid high drug prices.
In the United States, healthcare insurer Cigna decided, in 2023, to reverse its prior decision to cover the cost of the medication for all ALS patients, opting instead to cover "patients who meet certain clinical criteria", arguing that the drug is "experimental, investigational or unproven".
The Food and Drug Administration approved Amylyx Pharmaceuticals’ Relyvrio in September 2022, following a years-long advocacy campaign by patients with amyotrophic lateral sclerosis, or ALS, a ...