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 life-threatening 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.