Complete Response Letter on Evolus Botox Competitor

FDA has issued Evolus a complete response letter related to its BLA for DWP-450 (prabotulinumtoxinA) for treating glabellar lines, also known as frown lines, in adult patients. If approved, DWP-450 would be a competitor to Allergan’s Botox.

The FDA letter reportedly cited chemistry, manufacturing, and controls-related deficiencies. “No deficiencies were related to clinical or non-clinical matters,” the company says.  Evolus expects to respond with a complete submission to FDA within 90 days.  

Additionally, the company says it was recently provided with an Establishment Inspection Report related to contract-manufacturer Daewoong Pharmaceutical Co. “confirming the favorable completion of its pre-approval inspection of Daewoong’s manufacturing facility in South Korea...The DWP-450 manufacturing facility is fully validated by Daewoong under current good manufacturing practice requirements, and has capacity expected to meet anticipated product demand.”