Evolus has resubmitted its Biologics License Application (BLA) for its lead product candidate, DWP-450 (prabotulinumtoxinA), to the FDA.
The resubmission follows the receipt of a Complete Response Letter (“CRL”) from the FDA in May 2018 which necessitated the submission of additional data to the FDA for the completion of review of Evolus’ BLA. Deficiencies cited by the FDA in the CRL were isolated to items related to Chemistry, Manufacturing, and Controls (“CMC”) processes. No deficiencies were related to clinical, non-clinical or safety matters.
David Moatazedi, President and Chief Executive Officer of Evolus, commented, “Today we are resubmitting our BLA well ahead of our guided timeline and less than 90 days since receiving our CRL. We believe this submission gives us a line of sight to the anticipated approval and subsequent commercialization of DWP-450.”
Mr. Moatazedi continued, “We look forward to receiving notice next month of the FDA’s acceptance of our resubmission and the assignment of a new FDA action date. We are working towards the planned commercial launch of DWP-450 in spring 2019 as we further accelerate the build out of our sales and marketing team and finalize our go-to-market strategy.”Next Story