Botox competitor, Daxxify, gains FDA approval as anti-wrinkle drug

WASHINGTON — A new drug designed to reduce the appearance of facial wrinkles is poised to challenge Botox’s two-decade dominance in the marketplace.

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Nashville-based Revance Therapeutics announced Thursday that the U.S. Food and Drug Administration approved its new treatment, Daxxify, noting that the effects can last about six months, or longer than other products on the market, The New York Times reported.

According to The Wall Street Journal, Daxxify’s longevity could help Revance seize a considerable chunk of the lucrative and fast-growing market because its effects already outlast Botox injections by about two months.

Daxxify, also known as daxibotulinumtoxinA, was approved specifically for the “temporary improvement of frown lines in adults,” the Journal reported.

According to the Times, studies summitted to the FDA indicated that 80% of people receiving the treatment, which is injected into the face along worry lines, saw mild or no facial lines after four months.

“This marks what we think is the first real competitive threat to Botox,” Cowen Inc. analyst Ken Cacciatore told the newspaper, forecasting Daxxify to generate $1 billion in sales as early as 2030.

Although Botox first received FDA approval as an anti-wrinkle drug in 2002, Chicago-based AbbVie, a spinoff of Abbott Laboratories, acquired Botox as the focal point of a $63 billion deal in 2020, the Times reported.

Dr. Balaji Prasad, an analyst for investment bank Barclays, called Daxxify the most significant advance in the $3 billion facial-injection field since Botox — which now dominates 70 percent of the market — debuted.

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

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