Revance announces Orphan Drug Designation of RT002 for the Treatment of Cervical Dystonia

Revance Therapeutics announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for the Company’s product candidate, DaxibotulinumtoxinA for Injection (RT002), to treat cervical dystonia, a movement disorder of the neck, in adults.

“Cervical dystonia is a chronically painful and debilitating condition that can dramatically impact a patient’s quality of life. In our Phase 2 trial, RT002 appeared to be generally safe and well-tolerated and showed a clinically significant reduction and long-lasting improvement of subjects’ symptoms,” said Dan Browne, President and Chief Executive Officer at Revance. “We are pleased that the FDA granted Orphan Drug Designation for this promising therapy. Once we integrate the Orphan Drug Designation benefits into our development plans and receive feedback from both the FDA and the European regulatory authority on our proposed clinical path, we plan to announce the next steps for our cervical dystonia program in early 2018.”

The FDA Office of Orphan Products Development grants orphan designation to drugs and biologics intended for treatment of rare diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug designation provides certain developmental and financial benefits to sponsors planning to test a product for use in a rare disease or condition. These benefits may include tax credits for qualified clinical trials costs and exemption from FDA user fees.