Evolus boasts early resubmission of FDA-rejected Botox alternative
Evolus’ lead candidate, DWP-450 (prabotulinumtoxinA), is a 900 kDa purified botulinum toxin type A complex. As an alternative to Allergan’s onabotulinumtoxinA (Botox), the product is designed to temporarily improve the appearance of moderate to severe frown lines, also known as glabellar lines.
The resubmission comes less than 90 days after Evolus announced receipt of a complete response letter (CRL) from the US Food and Drug Administration (FDA).
The CRL flagged chemistry, manufacturing, and controls (CMC) processes, according to Evolus: “No deficiencies were related to clinical, non-clinical or safety matters.”
“We believe this [most recent] submission gives us a line of sight to the anticipated approval and subsequent commercialisation of DWP-450,” said CEO David Moatazedi in a statement.
“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,” he added. The firm expects to launch DWP-450 in spring 2019.
Evolus has overcome significant regulatory hurdles to get to the point of resubmission. In addition to the CRL, the firm’s contract manufacturing organisation (CMO), Daewoong Pharmaceutical, received a Form 483 with ten observations for its Hwaseong-si facility in South Korea last year. The CMO had specifically built the site to make DWP-450.
However, in May 2018, Evolus announced the FDA had validated the facility in an establishment inspection report to Daewoong.