Daxxify vials

Botox rival from Revance gets U.S. approval

Sept 7 (Reuters) – The U.S. Food and Drug Administrationon Thursday approved Revance Therapeutics’ (RVNC.O) anti-wrinkle injection, setting up a challenger for market leader AbbVie’s (ABBV.N) Botox that has long dominated the aesthetic market.

Revance said the injection, branded as Daxxify, had the ability to address the treatment’s duration, which was the greatest unmet need among the class of injections. Its shares surged 14% before the bell.

Botox revolutionized aesthetic medicine and became a hit among aging baby boomers and camera-conscious Generation X following its launch in 2002.

The drug was approved by U.S. regulators for treating glabellar lines – wrinkles between the eyebrows that make people look older.

Sales of Botox for cosmetic use came in at $862 million for the first six month of the year. Botox, which AbbVie acquired through its $63 billion purchase of Allergan, is also approved for therapeutic use, including for chronic migraine headaches.

The U.S. approval of Revance’s 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 injection will be the first product in the market for Revance as it expands its access to the growing $3.2 billion U.S. facial injectables market, the company said.

The company’s journey to get its drug approved has been long and arduous. The California-based drug developer shook the aesthetic industry in 2017 after data showed its drug reduced the severity of frown lines for about six months, almost double the duration achieved by Botox and other treatments.

However, the FDA declined to approve the drug in November last year, pointing to “deficiencies” at its manufacturing site during an inspection. The regulator had also delayed its decision on the injection in 2020 due to COVID-19 travel restrictions. (read more)

Reporting by Leroy Leo in Bengaluru; Editing by Anil D’Silva

Our Standards: The Thomson Reuters Trust Principles.

Source: Reuters