Evolus: US FDA validates troubled CMO site, but rejects BOTOX alternative
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Evolus, rejecting its biologics license application (BLA) for DWP-450 (prabotulinumtoxinA) for chemistry, manufacturing, and controls (CMC) deficiencies.
The candidate – an alternative to Allergan’s onabotulinumtoxinA (BOTOX) – is designed to temporarily improve the appearance of moderate to severe ‘frown lines’, also known as glabellar lines.
“We believe the CMC questions are very reasonable, since over half of the questions have already been completed and most were already in progress, which is why we believe we can respond to the FDA very quickly within the 90-day time frame,” a spokesperson told us.
“We now have 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,” the spokesperson added.
US FDA validates troubled CMO site
Evolus was however pleased to announce its contract manufacturing organisation’s (CMO’s) troubled facility had received FDA approval.
Last year, ten manufacturing violations landed Daewoong Pharmaceutical a Form 483 for its Gyeonggi-do-based site in South Korea – a facility purposely built to make DWP-450.
According to Evolus, the FDA has since issued an establishment inspection report (EIR) to Daewoong confirming the favourable completion of a pre-approval inspection.
Evolus says the Daewoong facility will support commercial production following the anticipated approval of its lead candidate.
“We appreciate our continued relationship with Daewoong and the work of our entire team as we continue to advance our BLA submission towards expected approval,” the Evolus spokesperson told us.