FDA Issues Complete Response Letter to Evolus for Manufacturing Issues for Botox CompetitorBy
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) over manufacturing issues to Evolus, an Irvine, California-based medical-aesthetics company, relating to its pending biologics license application for DWP-450 (prabotulinumtoxinA), purified botulinum toxin type A complex for treating glabellar lines (frown lines). The drug is a potential competitor to Allergan’s Botox (onabotulinumtoxinA), which had 2017 sales of $3.16 billion.
In the CRL, the FDA cited deficiencies related to chemistry, manufacturing, and controls (CMC) processes; the deficiencies were not related to clinical matters. Evolus says it plans to respond with a complete submission to the FDA within 90 days.
Daewoong Pharmaceutical, a Seoul, South Korea-based pharmaceutical company, is manufacturing DWP-450. The FDA issued an Establishment Inspection Report to Daewoong to confirm a 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 validated by Daewoong under cGMP requirements. Evolus plans to use the Daewoong facility to support commercial production following approval of DWP-450.
“…Deficiencies cited within the CRL are isolated to CMC matters, and we expect to respond comprehensively within 90 days,” said David Moatazedi, President and Chief Executive Officer of Evolus, in a May 16, 2018 company statement. “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.”