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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 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 and in stroke victims.
The most common side effects include bruising (contusions), problems walking (gait disturbances), and headaches.
The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.
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.
The half-life of edaravone is 4.5 to 6 hours and the half-lives of its metabolites are 2 to 3 hours. It is metabolized to a sulfate conjugate and a glucuronide conjugate, neither of which are active. It is primarily excreted in urine as the glucuronide conjugate form.
It suppresses reperfusion injury in animal models of stroke and improves stroke recovery after reperfusion therapy in humans.
Mitsubishi Pharma started a phase III clinical trial in ALS in 2011, in Japan, and by June 2015, it had been approved for that use in Japan. The company had received orphan drug designation for edaravone from the FDA and the EU by 2016.
It was approved for ALS in the US in 2017, based on a small randomized-controlled trial with people who had early-stage ALS in Japan, who were administered the medication for 6 months; it had failed two earlier trials in people with all stages of ALS.
In May 2017, I.V. edaravone was approved by the FDA to treat people with amyotrophic lateral sclerosis (ALS) in the United States. 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.
Efficacy of edaravone for stroke as an adjunct to regular reperfusion therapy has been reproduced in two retrospective studies of Japanese medical records.
A different oral formulation of edaravone from Mitsubishi Tanabe Pharma America (MT1186/MT-1186) was approved for medical use in the United States in May 2022. NDA Approval fda.gov The estimated 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. A global phase 3b study of MT1186 was halted in 2023 due to failure.
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. In the US the medication was approved for all people with ALS but it was unclear at approval whether insurers would agree to pay for the medication for all people with ALS, or only people in the early stages of the disease.
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