FDA Declines to Approve Evolus Inc's Rival Treatment to Botox

May 16, 2018

By Reuters Staff  

U.S. health regulators on Wednesday declined to approve Evolus Inc's rival product to Allergan Plc's Botox, citing certain deficiencies related to its potential treatment for frown lines.

DWP-450 is the company's potential treatment of glabellar lines, also known as frown lines, in adult patients.

The deficiencies cited by the U.S. Food and Drug Administration were isolated to items related to chemistry, manufacturing, and controls processes, the company said.

The FDA's decision was widely anticipated, after it had issued a "form 483", which outlined violations at the company's facilities following inspections in 2017.

FDA rejection of the application was likely, and an expected approval for the treatment could come by late summer, Cantor Fitzgerald analyst Louise Chen said in a note on Monday.

The company said that its partner Daewoong Pharmaceutical Co received a favorable inspection report of its manufacturing facility.

A likely delay in the commercial launch of the product would be a positive for Allergan, which is expected to face competition from other products, including a biosimilar from Revance Therapeutics.

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