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.
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 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.