Edimer Receives Fast Track Designation for EDI200
Edimer Pharmaceuticals, a biotechnology company focused on developing an innovative therapy for the rare genetic disorder, X-linked hypohidrotic ectodermal dysplasia (XLHED), today announced the receipt of Fast Track designation from the U.S. Food and Drug Administration (FDA) for EDI200, the company’s novel, proprietary, recombinant protein. XLHED is a rare orphan disease that causes a range of symptoms including lack of sweat glands, poor temperature control, respiratory problems, and hair and tooth malformations.
The Fast Track program of the FDA is a process designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or lifethreatening conditions and that demonstrate the potential to address unmet medical needs. A drug that receives Fast Track designation is eligible for more frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval. In addition it offers more frequent written correspondence from FDA about such things as the design of the proposed clinical trials. Fast Track designated drugs typically qualify for priority review which can further expedite the FDA review process.
"We are diligently working to develop EDI200 as the first treatment for XLHED and are delighted that the FDA recognizes the potential for this novel therapy to treat this serious, potentially life-threatening disorder," said Neil Kirby, PhD, President and Chief Executive Officer of Edimer. “Correction of developmental abnormalities early in the life of XLHED-affected patients may provide clinically-significant, life-long health benefits. We will continue to work collaboratively with clinical investigators, health authorities and patient advocacy groups around the world to develop EDI200.”
“This is a significant milestone in our long journey toward a treatment for our families. We applaud Edimer and the FDA for recognizing the importance of this product and the commitment to working toward an effective treatment. We couldn’t be more thrilled that this news coincides with Ectodermal Dysplasias Awareness Month,” said Judy Woodruff, Executive Director of the National Foundation for Ectodermal Dysplasias.
EDI200 is an ectodysplasin-A (EDA-A1) replacement protein, representing the first of a new class of molecules rationally designed to correct a specific developmental disorder. EDI200 has been shown to bind specifically to the EDA-A1 receptor, activating the signaling pathways that lead to normal development. EDI200 has demonstrated substantial and durable efficacy in mouse and dog models of XLHED with notable reduction in mortality and morbidity.