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Information regarding Radicava® approval in the United States

Radicava® approved for treatment of ALS in United States

On May 5, 2017, the Food and Drug Administration (FDA) approved Radicava® to treat patients with amyotrophic lateral sclerosis (ALS) in the United States. The active ingredient of Radicava® is edaravone. Edaravone was originally developed by the Japanese pharmaceutical company Mitsubishi Tanabe for the treatment of acute ischaemic stroke. Subsequently, clinical trials in ALS patients demonstrated that the progression of ALS with edaravone could be delayed. These trials were all carried out in Japan. Since 2015 edaravone is on the market for the treatment of ALS in Japan under the brand name Radicut®. Hereafter, FDA approval was requested for the US market which has now been obtained.

Radicava® is administered directly into a vein by means of a 60-minute infusion. Dosing is done in repeated treatment cycles of 28-days. Infusions are given in 10 of 14 days in the first two weeks, followed by a 14 days drug-free period ‘(drug holiday’). Radicava® may be administered in a hospital or by a health care professional at home.

Treeway is pleased with the approval of Radicava® in the United States. We feel supported by the recognition of the efficacy of edaravone by the FDA. The approval of Radicava® does not interfere with Treeway’s plans for TW001, the treatment we have in development for the oral administration of edaravone.