The Food and Drug Administration on Thursday approved the anti-wrinkle injection Daxxify, setting up competition for Botox, which has dominated the market for two decades.
Manufacturer Revance Therapeutics said its studies show the drug can temporarily improve moderate to severe frown lines for about six months, almost twice as long a period as Botox. The company in a statement said Daxxify will expand its access to the growing $3.2 billion facial injectables market.
Revance said Daxxify was generally safe and well tolerated with no serious treatment-related adverse events reported in the clinical trials. The drug “achieved clinically significant improvement with long-lasting results and high patient satisfaction,” the company said.
In a study of more than 2,700 patients, 98 percent of them had no or mild wrinkles at four weeks after injection. The median effect lasted six months, with some patients seeing results for as long as nine months.
Like Botox, Daxxify is a neuromuscular blocking agent. Similar to other such products, FDA warned its effects could spread to other areas of the body. FDA also warned of the potential for general muscle weakness or breathing difficulties with the use of the toxin-based treatments, though with Daxxify the most common side effects were headache and eyelid ptosis, a condition where the upper eyelid droops over the eye.
Revance did not disclose the price of its injection, which it touted as the most significant advance in the field of facial injection drugs in 30 years.
Revance said it is planning on rolling out Daxxify to high-volume injectors in the U.S., with an early training and education program at company headquarters in Nashville, followed by a broader commercial launch.