The US Food and Drug Administration (FDA) has declined to approve Evolus' application seeking approval of DWP-450 to treat glabellar lines in adult patients.
The regulator issued a complete response letter to Evolus citing deficiencies related to chemistry, manufacturing and controls processes.
Evolus noted that the FDA did not identify any deficiencies associated to clinical or non-clinical matters.
Evolus president and CEO David Moatazedi said the company expects to respond to the concerns within 90 days.
DWP-450 (prabotulinumtoxinA) is a 900 kilodalton (kDa) purified botulinum toxin type A complex. The product candidate’s marketing authorization application is currently also under review by the European Medicines Agency (EMA).
In another update, Evolus said that its partner Daewoong Pharmaceutical received a favorable inspection report from the FDA of its manufacturing facility, which makes DWP-450.
Evolus said the DWP-450 manufacturing plant in South Korea is fully validated by Daewoong under existing good manufacturing practice requirements, and has capacity expected to meet estimated product demand.
Evolus aims to use the Daewoong plant to support commercial production after the expected approval of DWP-450.
Moatazedi said: “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.”
Earlier this year, Evolus presented data from the European and Canadian Phase III EVB-003 head-to-head comparative trial, which demonstrated that its investigational prabotulinumtoxinA 900 kDa neuromodulator met its primary endpoint of non-inferiority at Day 30 in subjects with moderate to severe glabellar lines, also known as frown lines, compared to onabotulinumtoxinA (Botox).
The 150-day, multicenter, randomized, double-blind, active- and placebo-controlled, single-dose Phase III non-inferiority EVB-003 study assessed prabotulinumtoxinA and onabotulinumtoxinA, both 900 kDa botulinum toxin type A complexes, in subjects who felt their glabellar lines had an important psychological impact.