The FDA recently announced that it approved a new drug to treat amyotrophic lateral sclerosis or ALS, which is also commonly recognized and called Lou Gehrig’s disease. Radicava (edaravone) was first developed in Japan and is only the second ALS drug approved in the United States. The first one, Rilutek (riluzole) was introduced back in 1995.
Radicava to Slow the Deterioration
ALS is a progressive neurodegenerative disease that attacks the nerve cells responsible for voluntary muscle movement. Presently, there is no cure, and most patients die within 3 to 5 years of the diagnosis.
The newly approved Radicava has an intensive administration cycle. This treatment involves a one-hour infusion every day for 14 days. In its turn, this is followed by a two weeks break.
The following cycles involve a daily administration for 10 days out of 14. Which are then matched by another drug-free period lasting a couple of weeks. Also, the intravenous line, used for administering edaravone, is left in place indefinitely. This could potentially increase the risk of infections.
A six-month clinical trial carried out in Japan demonstrated the efficacy of Radicava. This involved 137 Japanese patients with ALS which received either edaravone or a placebo. After half a year had passed, the patients that received edaravone showed less decline than the ones in the placebo group.
This study also looked to determine this new drug’s potential adverse reactions. The most common side effects were bruising and gait disturbance.
There is evidence this ALS drug works best in early stage patients. It hasn’t been shown to prolong life, just to slow the decline caused by the disease. While the exact mechanism behind its efficacy isn’t well understood, researchers hypothesize that it targets oxidative stress on nerve cells and vascular endothelial cells.
Both ALS healthcare professionals and patients expressed excitement about this breakthrough. Some patients have already obtained it from Japan. Still, one of the issues with this treatment is the lack of hard evidence that Radicava prolongs life.
The cost of the ALS drug also comes as a problem at this stage. This treatment may cost patients around $145,000 a year. However, the drug’s producer, MT Pharma America, promised some co-pay assistance to patients with commercial insurance, adding that some may qualify for free treatments.
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