Acer Therapeutics Inc., a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and ultra-rare diseases with critical unmet medical need, today announced positive results from the pivotal clinical trial of EDSIVO (celiprolol) for the treatment of vascular Ehlers-Danlos Syndrome (vEDS). Acer’s retrospective source verified analysis of the trial data, including the primary and secondary endpoints, confirmed the data from a previously published randomized controlled clinical study of celiprolol. Acer will use this pivotal clinical data to support a New Drug Application (NDA) regulatory filing in the U.S. in the first half of 2018.
To Read the Complete Article at CheckOrphan, Click Here
Working on a cure for a rare disease? Need Breakthrough Therapy designation, Fast Track Designation, RMAT Designation, FDA or EMA Orphan Designations? The BioPharma Global Regulatory Team can help – We are the #1 US based not-for-profit Global regulatory affairs firm with cost-effective, time-efficient solutions to chaperone your path through the regulatory affairs process. Contact us at https://biopharmaglobal.com/contact/ or by phone +1(202)660-1826
Leave a Reply