Drug news
FDA issues Complete Response to NDA for Edsivo to treat Ehlers-Danlos syndrome
Acer Therapeutics Inc.has announced it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Edsivo for the treatment of vascular Ehlers-Danlos syndrome (vEDS). The CRL states that it will be necessary to conduct an adequate and well-controlled trial to determine whether celiprolol reduces the risk of clinical events in patients with vEDS. Acer plans to request a meeting to discuss the FDA’s response.
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