FDA Gives Green Light to Long-Awaited Botox Competitor
Revance’s newly approved Botox treatment, Daxxify, is getting ready to take on AbbVie’s competitor injectable. On September 8th, Revance announced the FDA approval of Daxxify, the first and only peptide-formulated Botox treatment with long-lasting results to reach the market. Daxxify has been shown to reduce wrinkles for up to six months and more.
The injected treatment temporarily removes moderate to severe glabellar (or frown lines) and is praised for its staying power. Whilst traditional Botox injections, such as AbbVie’s, last for three months, Revance’s Daxiffy has been shown to last up to between six and nine months.
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Daxxify is the first injected neuromodulator to be based on peptide exchange technology. It was initially due to receive FDA approval back in November 2020 but suffered delayed inspection due to the outbreak of the coronavirus pandemic.
“The FDA approval of DAXXIFY™ is a foundational achievement for the company as it marks the culmination of years of pioneering research and development,” Mark J. Foley, Chief Executive Officer at Revance, announced in an official press release. “It has been an incredible and rewarding journey to realise our vision and bring this disruptive innovation to an industry that has remained largely unchanged for over 30 years”
Daxxify’s key differentiator is its duration benefits which were established during a phase III trial with 2,700 patients and 4,200 treatments. The studies demonstrated that a single injection produced a powerful effect on wrinkles.
Daxxify is the first injected neuromodulator to be based on peptide exchange technology.
The approval of the new Botox treatment has been met with much excitement that some are mistakenly referring to it by the company’s name. However, Revance has little concern over Daxxify’s branding and identity and is already planning to expand the injectable’s applications further.
In particular, Revance is aiming to investigate Daxxify for its therapeutic applications. Currently, an FDA approval submission is planned for cervical dystonia, a painful condition caused by involuntary spasms of the neck muscles. A phase II study into upper lip spasticity has also been completed.
The commercial price of Daxxify remains yet unknown.
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