FDA Approves Revance’s Daxxify for Moderate-to-Severe Frown Lines

The FDA has approved Revance Therapeutics’ injection Daxxify (daxibotulinumtoxinA-lanm) for the temporary improvement of moderate-to-severe frown lines in adults.

Revance said Daxxify is the first and only long-acting neuromodulator that demonstrates a median duration of six months and up to nine months for some patients.

Agency approval was based on data from a phase 3 clinical trial, with 74 percent of participants achieving an improvement of two grades or more in glabellar lines at week four.

The company previously received a Complete Response Letter (CRL) for its Biologics License Application in October 2021, due to deficiencies found during an FDA premarket inspection of a Revance manufacturing facility.