FDA issues a Complete Response Letter to Evolus for DWP 450 a proposed treatment for glabellar lines.

Evolus, Inc.has announced updates related to the regulatory progress of its pending Biologics License Application (�BLA�) for DWP 450 (prabotulinumtoxinA) to the FDA. The FDA issued an Establishment Inspection Report (�EIR�) to Daewoong Pharmaceutical Co. Ltd.confirming the favorable completion of its pre-approval inspection of Daewoong�s manufacturing facility in South Korea which was purpose built for production of DWP 450. 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. Evolus plans to utilize the Daewoong facility to support commercial production following the anticipated approval of DWP 450.

Additionally, the FDA has issued a Complete Response Letter to Evolus related to its BLA for DWP 450 for the treatment of glabellar lines, also known as frown lines, in adult patients. In the CRL, deficiencies cited by the FDA were isolated to items related to Chemistry, Manufacturing, and Controls processes. No deficiencies were related to clinical or non-clinical matters. Evolus expects to respond with a complete submission to FDA within 90 days.