FDA Names AR101 Orphan Drug, Clears Way for Vascular EDS Trial

FDA Names AR101 Orphan Drug, Clears Way for Vascular EDS Trial

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FDA Names AR101 Orphan Drug, Clears Way for Vascular EDS Trial

AR101 (enzastaurin), an orally available small molecule being developed to treat vascular Ehlers-Danlos syndrome (vEDS) by Aytu BioPharma, has been designated an orphan drug by the U.S. Food and Drug Administration (FDA). A request to launch a pivotal clinical trial in patients was also cleared by the FDA. Orphan drug status is given to accelerate the clinical development of investigational treatments for rare diseases, those that affect less than 200,000 people in the U.S. Benefits of…

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