Author: King David
Daxxify, an anti-wrinkle injection from Revance Therapeutics, has been approved by the FDA. The drug can temporarily reduce frown lines within six months.
That is said to be twice as long as Botox, which has dominated the market for two decades. According to the company, DaxXify will increase its chances in the $3.2 billion facial injectable industry.
The new treatment effectively freezes wrinkles by acting as a neuromuscular blocking agent, similar to AbbVie’s Botox. Based on the studies presented to the FDA, the solution significantly outperformed the impact of a placebo. Nearly 80% of treatment providers reported pale or light lines on the face four months after injection, and about half noticed an effect in six months.
The approval was a result of data from numerous patients and treatments.
Data from over 2,700 patients and about 4,200 treatments were used to the safety and potency of Daxxify. According to the company, 98% of study participants had no or minor wrinkles four weeks after injection. Some patients continued to see improvement after their treatments for up to nine months, with a six-month median time.
According to Revance, Daxxify was discovered to be safe and well tolerated. No significant adverse event was discovered during the clinical studies.
The company reported that headache (6%) was the most frequent adverse event associated with treatment in the pivotal studies. The second was a drooping eyelid or eyelid ptosis 2% and facial paresis, including facial asymmetry (1%).
Daxxify’s effects could extend from the injection site to other places. As a result, the FDA and the firm warned that similar symptoms with botulinum toxin effects could be produced.
These signs have been noted anywhere between hours and weeks following the injection. The warning adds that breathing and swallowing issues can be fatal and that deaths has been reported.
It is the first time in over 30 years that a truly innovative neurotoxin has been brought to the market.
Daxxify was originally scheduled to get FDA approval in November 2020, but the epidemic slowed its inspection. Inspections eventually gained access to Revance’s production site, where they discovered issues with quality control and documentation.
A detailed response letter was then issued to Revance by the FDA in October of last year.
The FDA approved the changes in July after Revance resolved all five problems mentioned in the CRL. Nevertheless, the regulator later noted three additional issues in a Form 483 citation. But for each, the business had an easy fix. The route to get here has been arduous, Foley added.
We’re ecstatic since this neurotoxin will represent the first time in more than 30 years that it has been released onto the market.
Naturally, the first was Allergan’s Botox, which debuted on the market in 1989. Botox earned $4.7 billion in sales last year for AbbVie, which spent $63 billion to acquire Allergan in 2019. Botox has both cosmetic and therapeutic uses.
The key differentiator
Daxxify’s ability to endure is what sets it apart. Botox injections last for 3 months, while Daxxify can last for 6 months, and up to nine months in some people.
In phase 3 trials with 2,700 patients and 4,200 treatments, the durational advantages of Daxxify were demonstrated. The trials revealed that a single injection might significantly reduce wrinkles. According to Foley, the most unfulfilled desire with toxins is duration. “Our label is great. We collaborated extensively with the agency to incorporate 36 weeks of data into our label, allowing us to substantiate marketing assertions.
The Bottom Line
The cost of Daxxify for frown lines has not been disclosed by the firm. The business will use a preview plan for its launch for two quarters. “We want to get this into the hands of a select few doctors so they can learn how to use it to achieve the best results,” said Foley. Before the wide commercial rollout, we wanted to offer a few professionals a chance to test it out.