Evolus has secured approval for Jeuveau.

After overcoming concerns about manufacturing problems, Evolus has managed to secure approval from the U.S. Food and Drug Administration for Jeuveau, a 900-kDa purified botulinum toxin–type product for the reduction of glabellar lines associated with corrugator and/or procerus muscle activity in adults –– in other words, frown lines. The approval was based on phase II trials that showed higher responder rates for Jeuveau than placebo or Botox. The company plans to sell the product at a 20–25% discount compared with Botox, the market leader manufactured by Allergan. 

Even before the approval was issued, however, Allergan filed a trade complaint at the U.S. International Trade Commission in Washington asserting that Jeuveau was developed using R&D results stolen from its partner Medytox. Specifically, the company claims that a former staff scientist delivered the information to Daewoong, which developed candidate DWP-450 and then out-licensed this product to Evolus. Daewoong sells the product in South Korea as Nabota. Medytox had previously filed a trade complaint in 2017 in South Korea against Daewoong.

The cases are pending, and it is unclear whether Allergan and Medytox will have rulings go their way. Both Daewoong and Evolus have denied the allegations and are building out a specialty sales force. Evolus expects to receive EU approval for Jeuveau by mid-2019 and will launch the product in Canada in the spring. Even if Allergan and Medytox win their complaints, Botox will soon have more competition from products being developed by Revance Therapeutics and Hugel.