The US approval of Daxxify was based on a late-stage trial of over 2,700 patients that showed the injection had a six-month median duration, with some patients even showing the effect at nine months.
Revance Therapeutics said on Thursday it had received the U.S. Food and Drug Administration's approval for its injection that could rival AbbVie's Botox. The company said Daxxify, its treatment for wrinkles that appear as people become older, has the ability to address the duration of treatment effect, which it believes is the greatest unmet need among the class of injections. The U.S. approval of Daxxify was based on a late-stage trial of over 2,700 patients that showed the injection had a six-month median duration, with some patients even showing the effect at nine months. The company received a "complete response letter" in November last year after the regulator pointed to "deficiencies" at its manufacturing site during an inspection
