FDA rejects Evolus Botox rival

May 16, 2018

U.S. regulators have declined to approve a product that looked poised to rival Allergan’s Botox. 

Developed by Evolus, the treatment, called DWP-450, aims to clear up glabellar or frown lines in adults. But according to the company, the FDA announced this week that it will not approve the product because of deficiencies related to the chemistry, manufacturing and controls process for the product. The FDA also said that the deficiencies are “manageable,” and the company hopes to still get the product to market by this time next year.

The delay was good news for Allergan, whose stocks rose by 2.1 percent the morning of the announcement. Threats are coming from other directions, however: Earlier this year, Revance Therapeutics and Mylan joined forces to develop a biosimilar to Botox.

Read the full CNBC report here.

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