FDA Approves First New ALS Drug in More Than 2 Decades

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.

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 an associate editor at BioCentury, which provides news and information about the biotechnology and pharmaceutical industries. Prior to joining BioCentury in 2019, Jonathan worked for MedShadow as content editor. He has been an editor and writer for multiple pharmaceutical, health and medical publications, including The Pink Sheet, Modern Healthcare, Health Plan Week and Psychiatry Advisor. He holds a BA from Tufts University and is earning an MPH with a focus on health policy from the CUNY Graduate School of Public Health & Health Policy.


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