BioTuesdays

FDA clears Revance’s DAXXIFY injection for cervical dystonia

The FDA approved the first therapeutic indication for Revance Therapeutics’ (NASDAQ:RVNC) DAXXIFY for injection for the treatment of cervical dystonia in adults.

Cervical dystonia is a chronic, debilitating disease in which the neck muscles contract involuntarily, causing abnormal movements, pain and awkward posture of the head and neck.

DAXXIFY was previously approved by the FDA for the temporary improvement of frown lines in adults in September 2022 and is the first innovation in neuromodulator product formulation in more than 30 years.

In a statement, Mark Foley, CEO of Revance, said expansion of the
DAXXIFY label to include the first therapeutic indication unlocks a new market opportunity for DAXXIFY following the product’s recent launch in the aesthetics market.

“DAXXIFY’s differentiated efficacy, duration and safety profile can help physicians deliver long-lasting symptom relief to patients suffering from cervical dystonia, while also helping payers address the total cost of care for this population,” he added.