On May 5, the FDA approved the first new treatment in 22 years for amyotrophic lateral sclerosis (ALS). The drug, Radicava (edaravone), has been found to slow down the decline of physical ability in ALS patients by a third. Find out more about the FDA approval of Radicava here.
Here are some important things to know about Radicava:
- The drug underwent a phase 3 clinical trial in Japan and South Korea where 137 ALS patients were given either Radicava or a placebo. The group given Radicava experienced a 33 percent reduction in the decline of their physical abilities compared to the placebo group.
- Radicava works by reducing the oxidative stress in the body. People with ALS have high levels of oxidative stress.
- Radicava is administered via intravenous infusions. Initially, patients have a daily infusion for two weeks and then have two weeks’ rest. After that, they need to have 10 consecutive daily infusions followed by two weeks’ rest.
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- Each infusion takes around an hour to complete.
- The dosage of each infusion is 60 mg.
- The cost of each Radicava infusion is $1,000 and treatment costs $146,000 annually.
- Radicava should be available to ALS patients in the U.S. by August.
- The most common side effects associated with the drug are headaches, bruising and gait problems.
- Radicava infusion contains sodium bisulfite which is known to cause both mild and severe allergic reactions in some people (particularly those with asthma).
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