The DWP-450 will be marketed in Canada through Evolus’ partner Clarion Medical Technologies.
Clarion is a provider of medical and aesthetic equipment and consumables to hospitals, clinics and private medical practitioners in the country.
PrabotulinumtoxinA is a 900 kilodalton (kDa) purified botulinum toxin type A complex.
Evolus president and CEO David Moatazedi said: “The marketing approval of DWP-450 in Canada represents a key achievement for Evolus in our regulatory efforts as it is the first approval worldwide of our neurotoxin, and ahead of our guided timeline in Canada.
“DWP-450 offers a significant and valuable competitive opportunity given the meaningful gap between the neurotoxin market leader and other available products, and we look forward to our partner providing DWP-450 to physicians and consumers in Canada in the first half of 2019.”
DWP-450 is being assessed for marketing approval in the US and other areas.
The company expects to launch the DWP-450 in the US by next spring. An opinion is anticipated from the Committee for Medicinal Products for Human Use (CHMP) in the first quarter of next year.
If the CHMP gives a favorable opinion, it expects approval of the MAA in the first half of next year.
Evolus chief medical officer and R&D head Rui Avelar said: “This marketing approval positions Evolus with a competitive advantage as the first known 900 kda molecule approved since Botox.
“The approval from Health Canada is based on the results from our clinical program that included our EV-001 and EV-002 pivotal phase III studies in the United States and supported by our EVB-003 pivotal Phase III study in the European Union and Canada.”
Earlier this year, the US Food and Drug Administration issued an Establishment Inspection Report (“EIR”) to Daewoong Pharmaceutical confirming the 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 plant is fully validated by Daewoong under current good manufacturing practice requirements, and has capacity expected to meet anticipated product demand.
Evolus aims to use the Daewoong facility to support commercial production after the anticipated approval of DWP-450.
