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US Food and Drug Administration

Amyotrophic lateral sclerosis treatment approved by FDA

The US Food and Drug Administration (FDA), which is responsible for evaluating the safety and efficacy of medicines in the United States, has approved edaravone (Radicava, MT Pharma America, Inc) for the treatment of patients with amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, as it is commonly known.

ALS is a rare, progressive disease that attacks and kills nerve cells causing them to lose the ability to activate voluntary muscles that control movements such as chewing, walking and breathing. ALS patients often die from respiratory failure within three to four years of initial symptoms.

Edaravone, which is administered as an intravenous infusion, is the first new treatment to be approved for ALS by the FDA for many years. The initial treatment cycle involves daily dosing for 14 days followed by a 14-day drug-free period; this is followed by dosing on 10 of the 14 days, followed by a 14-day-drug free period.

The approval for the drug was given on the basis of a six-month clinical trial conducted in Japan. The 137 participants were randomly given either edaravone or placebo. After 24 weeks, the group who received edaravone declined less on a clinical assessment of daily functioning, compared with the placebo group.

The most common side effects reported from participants in the trial were bruising and gait disturbance. However, other side effects that might occur include hives, swelling or shortness of breath resulting from allergic reactions to an ingredient in the drug called sodium bisulfite.

 

Citation: The Pharmaceutical Journal URI: 20202726

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