The Dutch biotechnology company Treeway, founded by the ALS patients and entrepreneurs Bernard Muller and Robbert Jan Stuit (see Jan 2015 news story) has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to its ALS candidate therapy TW001. TW001 is a reformulated therapeutic drug (edaravone) that acts as a radical scavenger and has demonstrated efficacy in previous clinical trials (for an undisclosed indication). The orphan drug designation will help promote a US clinical program in ALS, and will grant financial incentives for the company. The decision by the FDA follows that of the European Medicines Agency, which granted the drug orphan status in November 2014.
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