The FDA approval was conditioned on Mitsubishi Tanabe completing several additional studies to clarify the risks of cancer and liver disease, among other effects of the medication.Formulation of edaravone by mouth called TW001 (mixture of the edaravone and SBE-HP-βCD ) has been under development by Treeway for ALS; as of 2015, it had successfully completed Phase I trial and had received orphan status in the US and in the European Union.An oral formulation of edaravone was approved for medical use in the United States in May 2022. The effectiveness of oral edaravone is based on a study that showed comparable levels of oral edaravone in the bloodstream to the levels from the IV formulation of edaravone. The efficacy of edaravone for the treatment of ALS was previously demonstrated in a six-month clinical trial that served as the basis for approval in 2017. In that trial, 137 participants were randomized to receive edaravone or placebo. At week 24, individuals receiving edaravone declined less on a clinical assessment of daily functioning compared to those receiving placebo. Society and culture
Economics
The price for the medication when it launched in Japan for stroke in 2001, was set by the Japanese government at 9,931 yen/ampule.When the medication launched in Japan for ALS in 2001, the price was $35,000; the price in Japan in 2017 was $5,000, the US price at launch was around $145,000.
Edaravone, sold under the brand name Radicava among others, is a medication used to treat stroke and amyotrophic lateral sclerosis (ALS). It is given by intravenous infusion and by mouth.The most common side effects include bruising (contusions), problems walking (gait disturbances), and headaches.The mechanism by which edaravone might be effective is unknown. The medication is known to be an antioxidant, and oxidative stress has been hypothesized to be part of the process that kills neurons in people with ALS.The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. Medical uses
Edaravone is used to help people recover from stroke in Japan, and is used to treat ALS in the US and Japan. Adverse effects
The label carries a warning about the potential for hypersensitivity reactions to edaravone, and adverse effects include bruising, gait disturbances, headache, skin inflammation, eczema, problems breathing, excess sugar in urine, and fungal skin infections.The following adverse effects in at least 2% more people given the medication than were given placebo: bruising, gait disturbances, headache, skin inflammation, eczema, problems breathing, excess sugar in urine, and fungal skin infections.There is no data on whether it is safe for pregnant women to take, and it is unknown if edaravone is secreted in breast milk. Pharmacology
The mechanism by which edaravone might be effective in ALS is unknown.