Daewoong Pharmaceutical Nabota Demonstrates Long-Lasting 6-Month Efficacy in High-Dose Clinical Trial

Announcement by US Partner Evolus
Clinical Trial of 'Extra Strength' with Double the Dosage Capacity

[Asia Economy Reporter Myunghwan Lee] Daewoong Pharmaceutical announced on the 3rd that its botulinum toxin 'Nabota' (export name to the U.S.: Jeuveau) showed positive interim results regarding long-lasting effects in a high-dose clinical trial conducted on patients with glabellar lines.

Daewoong Pharmaceutical's U.S. partner, Evolus, presented the interim results of the Phase 2 'Extra Strength' clinical trial at the International Master Course on Aging Science (IMCAS) held in Paris, France, on the 28th of last month. The trial involved administering a high dose of Jeuveau (40 units), approximately double the existing 20 units, and observing the improvement effects on glabellar lines over six months.

This clinical trial began in March last year and involved 150 patients under 65 years old with moderate to severe glabellar lines. The study was conducted as a multicenter, double-blind, randomized trial. Evolus confirmed the long-lasting effect of 40 units for six months or 26 weeks and demonstrated safety without serious adverse events. The active control groups for the 40-unit Jeuveau were 20 units of Botox and 20 units of Jeuveau, with similar adverse event outcomes compared to the active control groups.

The trial evaluated durability at 3 days, 7 days, and 12 months with 30-day intervals. The assessment was based on interim analyses of the glabellar line scale and the global aesthetic improvement scale. According to the study, approximately 26 weeks were required for 50% of patients treated with the high-dose Jeuveau to return to their pre-treatment state.

This clinical trial demonstrated that high-dose Jeuveau offers a longer treatment interval option, which Daewoong Pharmaceutical explained is expected to lead to increased convenience and preference by reducing the number of clinic visits for patients.

Seongsu Park, Vice President of Daewoong Pharmaceutical, stated, "Based on the meaningful results and scientific data derived from the high-dose administration trial by our partner Evolus, we plan to market in major botulinum toxin markets such as the U.S., Europe, and Canada. Both companies will continue clinical trials to prove Nabota's efficacy and safety and expand its global market share."

Daewoong Pharmaceutical's botulinum toxin 'Nabota' exported to the United States as 'Jeuveau'. / Photo by Daewoong Pharmaceutical