Edavarone, known by the brand name Radicava, has become the first new drug to be approved by the FDA for the treatment of amyotrophic lateral sclerosis, better known as ALS or Lou Gehrig’s disease, in more than twenty years. Radicava was approved for use in the U.S. on Friday, May 5, making it the first ALS drug approved since riluzole, approved in 1995.
Radicava was tested in Japan, where the researchers found edavarone led to a statistically significant reduction in the rate of decline in the level of daily functioning due to ALS. According to MT Pharma, the makers of Radicava, edavarone led to a 33% reduction in the rate of decline as compared to the placebo group. The FDA’s neurology products division then contacted the Japanese researchers with a view to filing a marketing application in the U.S.
ALS Patients Have Social Media to Thank
ALS, popularly known as Lou Gehrig’s disease after the famous baseball player forced to retire from the sport due to it, has generated renewed interest after the ALS ice bucket challenge went viral on social media. The increased prominence of the disease in public awareness is illustrated by the fact that the ice bucket challenge alone raised US$115 million for ALS research in about two months. The burst of funding has allowed researchers to conduct better studies and formulate better compounds for ALS treatment. Around 15,000 Americans are estimated to suffer from ALS, making this a significant step in making ALS treatment accessible to every patient.
The required use of Radicava can cost up to US$150,000 per year, with each infusion being priced at US$1,000. However, the maker has stated they will co-pay assistance for insured patients as well as patients who don’t have insurance but meet certain other requirements.