The approval of Evolus’ DWP-450 (prabotulinumtoxinA) has hit a snag, reportedly due to issues at the appointed manufacturing facility. The U.S. Food & Drug Administration issued a complete response letter (CRL) to the company’s biologic license application for DWP-450 outlining concerns that must be addressed before the FDA can approve the new neurotoxin for marketing in the U.S.
In a call to investors and a publicly released statement, the company did not elaborate on the FDA’s concerns other than to note that the deficiencies cited related to Chemistry, Manufacturing, and Controls (CMC) processes, not clinical performance of the product.
“We are pleased with the progress we continue to make with the FDA, and this CRL confirms our confidence in our clinical submission. Deficiencies cited within the CRL are isolated to CMC matters and we expect to respond comprehensively within 90 days,” said David Moatazedi, president and CEO of Evolus. “Overall, we view these updates as positive, which together give us the line of sight necessary to build our commercial infrastructure. We look forward to working closely with the FDA and remain committed to bringing DWP-450 to market by spring 2019.”