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F.D.A. OKs Daxxify, an Anti-Wrinkle Drug and Botox Competitor

The Food and Drug Administration has approved a new drug that reduced the appearance of facial wrinkles for about six months, fueling competition in a market dominated by Botox for decades.

Revance Therapeutics, maker of the new treatment, Daxxify, announced its approval Thursday morning, saying its effects — by injection into the face along worrisome lines — lasted longer than other products on the market.

Like AbbVie’s Botox, the new treatment is a neuromuscular blocking agent that essentially freezes wrinkles. It is also a botulinum toxin that, when used as directed, is not detected in the patient’s bloodstream.

in studies filed with the FDAthe treatment far outweighed the effect of a placebo, with about 80 percent of the practitioners seeing no or mild facial lines four months after the injection and about half seeing the effect for six months.

dr. Balaji Prasad, who works as an analyst for the Barclays Investment Bank on specialty pharmaceuticals, said the drug was the most significant advance in the $3 billion facial injection drug market since Botox — which now dominates 70 percent of the market — for the first time. was first adopted decades ago.

“Users don’t have to go once every three months,” said Dr. Prasad. “In a world where time is of the essence, having a product with a long duration factor is extremely helpful.”

Mark Foley, the chief executive of Revance Therapeutics, said in an interview Thursday that the company has spent years trying to discover an effective neuromuscular blocker that can be applied to the skin without a needle. In the process, it found a way to keep the formula stable with peptide technology, rather than the animal protein or human serum commonly used. That led to the product’s approval, which he said the company has already started testing for several medical issues.

“It also opens the door for what we can do with therapies,” said Mr. Foley. “When you think about migraines, cervical dystonia, overactive bladder, there’s also a huge medical opportunity.”

The FDA approved Botox in 2010 as a treatment for chronic migraines.

One of the Revance studies submitted to the FDA for the aesthetic use of Daxxify found that users experienced more side effects than those given a placebo; six percent got a headache and two percent got a drooping eyelid.

The FDA warned of the possibility of generalized muscle weakness or breathing difficulties when using toxin-based treatments, but said no such symptoms existed. were noted with Daxxify.

The drug had a difficult road to approval. Based in Nashville, Revance initially hoped for approval in November 2020, but the FDA postponed an inspection of the manufacturing site due to travel restrictions imposed during the coronavirus pandemic, said Dr. Prasad.

In June 2021, the FDA conducted the inspection and discovered problems with the company’s quality control process and working cell bank, or a collection of cells containing the drug’s active ingredient, the agency’s data shows. Mr Foley said those concerns were resolved once the company moved into a new working cell bank.