FDA Approves Daxxify, a New Anti-Wrinkle Drug

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

Revance Therapeutics, the maker of the new treatment, Daxxify, announced the approval on Thursday morning, saying its effects — by injection into the face along worry 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, which, when used as directed, is not detected in the patient’s bloodstream.

In studies submitted to the F.D.A., the treatment far exceeded the effect of a placebo, with about 80 percent of the treatment providers seeing no or mild facial lines at four months after injection and about half seeing the effect through six months.

Dr. Balaji Prasad, who covers specialty pharmaceuticals as an analyst for Barclays Investment Bank, said the medication was the most significant advance in the $3 billion field of facial injection drugs since Botox — which now dominates 70 percent of the market — was first approved decades ago.

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

Mark Foley, the chief executive of Revance Therapeutics, said in an interview on Thursday that the company spent many years trying to discover an effective neuromuscular blocking agent that could be applied to the skin without a needle. In the process, it found a way to keep the formula stable with peptide technology, instead of the animal protein or human serum that was typically used. That led to the product’s approval, which he said the company has already begun to test for a variety of medical concerns.

“It also opens up the door for what we can do with therapeutics,” Mr. Foley said. “If you think of migraines, cervical dystonia, overactive bladder, there’s a huge medical opportunity as well.”

The F.D.A. approved Botox as a treatment for chronic migraines in 2010.

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

The F.D.A. warned of the potential for general muscle weakness or breathing difficulties with the use of the toxin-based treatments, but said no such symptoms were noted with Daxxify.

The drug had a rocky road to approval. Revance, based in Nashville, initially hoped for approval in November 2020, but the F.D.A. postponed an inspection of the manufacturing site because of the travel restrictions imposed during the coronavirus pandemic, according to Dr. Prasad.

In June 2021, the F.D.A. conducted the inspection and discovered problems with the company’s quality control process and working cell bank, or a collection of cells that contains the drug’s active ingredient, agency records show. Mr. Foley said those concerns were resolved once the company got a new working cell bank in operation.

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