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FDA Approves First New ALS Drug in More Than 2 Decades


By Jonathan Block

May 8, 2017

FDA Approves First New ALS Drug in More Than 2 Decades

The FDA has approved the first new drug to treat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, in more than 20 years.

In clinical trials, the drug, Radicava (edaravone), reduced the rate of functional decline by one-third better than placebo. Before the approval, the only other drug approved to treat ALS was riluzole.

For treatment, a patient begins with daily dosing of Radicava for 14 days, followed by 2 weeks drug free. Subsequent treatment consists of receiving infusion on 10 of 14 days, followed by 14 days drug free.


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The most common adverse events reported with Radicava, which is given via intravenous infusion, were bruising and abnormal walking. However, there are also other serious risks associated with the drug, such as hives, swelling, shortness of breath, and allergic reaction to an ingredient in the medication.

The medication should become available in August.

Jonathan Block

Jonathan Block

Jonathan Block is MedShadow’s content editor. He has previously worked for Psychiatry Advisor, Modern Healthcare, Health Reform Week and The Pink Sheet.

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Last updated: May 8, 2017