Revance Says FDA Accepts sBLA for Daxxify to Treat Cervical Dystonia

By Stephen Nakrosis

Revance Therapeutics, Inc. said the U.S. Food and Drug Administration will review the company's supplemental biologics license application for Daxxify as a treatment for cervical dystonia in adults.

The company said Daxxify, or DaxibotulinumtoxinA-lanm, is an injection to treat cervical dystonia, a chronic and debilitating neurologic condition affecting neck muscles.

Mark J. Foley, the company's chief executive, said "positive results from our ASPEN Phase 3 clinical program demonstrate the potential of Daxxify to bring sustained symptom relief to cervical dystonia patients, along with the potential for reduced frequency of annual injections."

The company said Daxxify was approved by the FDA for temporary improvement of moderate to severe glabellar lines in adults.

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

January 06, 2023 18:34 ET (23:34 GMT)

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