FDA Approves Daxxify, a New Anti-Wrinkle Drug

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

Revance Therapeutics, maker of the new treatment, Daxxify, announced its approval on Thursday morning, saying its effects – by injection into the face along with anxiety marks – last longer than other products on the market.

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

In research submitted to FDAThe treatment far outstripped the placebo effect, with about 80% of people seeing no or no wrinkles on their faces 4 months after injection and about half seeing results after 6 months.

Dr Balaji Prasad, head of specialty pharmaceuticals as an analyst for Barclays Investment Bank, said the drug was the most significant step forward in the $3 billion field of facial injections. dollars since Botox – now 70% of the market – was approved for the first time in decades. formerly.

“Users don’t have to go every three months,” says Dr. Prasad. “In a world where time is of the essence, having a product that has a long time element is extremely helpful.”

Mark Foley, chief executive officer of Revance Therapeutics, said in an interview on Thursday that the company has spent years finding an effective neuromuscular blocking agent that can be applied to the skin without the need for a needle. . In the process, they found a way to keep the formula stable using peptide technology, instead of the commonly used animal protein or human serum. That led to the product’s approval, he said the company had already begun testing for a range of medical concerns.

“It also opens the door to what we can do with therapeutics,” Mr. Foley said. “If you think about migraines, cervical dystonia, overactive bladder, the medical opportunity is also huge.”

FDA Botox Approved as a Treatment for Chronic Migraines in 2010.

One of the Revance studies submitted to the FDA on the cosmetic use of Daxxify found that users experienced more side effects than those taking a placebo; six percent had headaches and two percent had drooping eyelids.

The FDA has warned of the possibility of general muscle weakness or shortness of breath when using toxin-based treatments, but says no such symptoms has been credited with Daxxify.

Drugs already have a path to approval. Revance, based in Nashville, originally hoped for approval in November 2020, but the FDA postponed the inspection of the manufacturing site because of travel restrictions imposed during the coronavirus pandemic, according to Dr. .

In June 2021, the FDA conducted an inspection and problem detected with the company’s quality control process and the active cell bank, or set of cells containing the drug’s active ingredient, agency records show. Mr. Foley said those concerns were resolved when the company had a new mobile bank up and running.

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