Botox rival from Revance gets U.S. approval

Sept 7 (Reuters) - The U.S. Food and Drug Administration on 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's injection, branded Daxxify, has shown in a study that it can reduce the severity of frown lines for about six months, nearly double than that of Botox, and the California-based drug developer is pinning its hopes on that outcome to help grow market share.

The injection provides a compelling alternative to existing products, with the ability to deliver long results with as few as two treatments per year, Revance Chief Executive Officer Mark Foley said on a conference call.

Shares of Revance surged 12% after the injection became the company's first ever product to be cleared, giving it access to the growing $3.2 billion U.S. market for facial injectables dominated by Botox.

Botox, an injection of a purified form of botulinum toxin that paralyzes muscles, 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 half 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.

Revance did not disclose the price of its injection, citing competition concerns and volume discounts to injectors, but has hinted that it will be relatively higher due to the drug's durability.

Cowen and Co analyst Ken Cacciatore said physicians were expecting Daxxify to reach half the size of Botox in three years, based on a recent survey, and that it would easily exceed $1 billion in sales.

Reporting by Leroy Leo in Bengaluru, Writing by Ankur Banerjee; Editing by Anil D'Silva

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