The Food and Drug Administration has approved a latest drug that reduced the looks of facial wrinkles for about six months, spurring competition in a market that for many years has been dominated by Botox.
Revance Therapeutics, the maker of the brand 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 in the marketplace.
Like AbbVie’s Botox, the brand new treatment is a neuromuscular blocking agent that essentially freezes wrinkles. It’s also a botulinum toxin, which, when used as directed, isn’t detected within 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 4 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 essentially the most significant advance within the $3 billion field of facial injection drugs since Botox — which now dominates 70 percent of the market — was first approved many years ago.
“Users do not need to go once every three months,” Dr. Prasad said. “In a world where time is of the essence, having a product with a protracted duration factor is amazingly useful.”
Mark Foley, the chief executive of Revance Therapeutics, said in an interview on Thursday that the corporate spent a few years attempting to discover an efficient neuromuscular blocking agent that could possibly be applied to the skin with no needle. In the method, it found a strategy to keep the formula stable with peptide technology, as a substitute of the animal protein or human serum that was typically used. That led to the product’s approval, which he said the corporate has already begun to check for a wide range of medical concerns.
“It also opens up the door for what we will do with therapeutics,” Mr. Foley said. “When you consider migraines, cervical dystonia, overactive bladder, there’s an enormous medical opportunity as well.”
The F.D.A. approved Botox as a treatment for chronic migraines in 2010.
One in all the Revance studies submitted to the F.D.A. for the aesthetic use of Daxxify found that users experienced more unintended 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 respiratory difficulties with using 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, however the F.D.A. postponed an inspection of the manufacturing site due to travel restrictions imposed throughout the coronavirus pandemic, based on Dr. Prasad.
In June 2021, the F.D.A. conducted the inspection and discovered problems with the corporate’s quality control process and dealing cell bank, or a group of cells that accommodates the drug’s energetic ingredient, agency records show. Mr. Foley said those concerns were resolved once the corporate got a latest working cell bank in operation.