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The newly approved drug was shown to slow the progression of symptoms of ALS in a Phase 2 trial.
The Food and Drug Administration (FDA) has approved a new drug to treat amyotrophic lateral sclerosis (ALS)—and it’s controversial. The medication, called Relyvrio, was given the green light ...
Health reporter Anjalee Khemlani outlines the circumstances behind the FDA's approval of a new ALS treatment drug amid high drug prices.
The FDA approval was conditioned on Mitsubishi Tanabe completing several additional studies to clarify the risks of cancer and liver disease, among other effects of the medication. [ 14 ] [ 15 ] A formulation of edaravone by mouth, which is a mixture of edaravone and SBE-HP-βCD, [ 16 ] has been under development by Ferrer (called FAB122) and ...
In the last year, the FDA has approved two new drugs for ALS, after a nearly 20-year drought of new options. ... Most people die within three to five years of their first symptoms.
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".
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