Daewoong Pharmaceutical announced today that it has submitted an Application for Product Authorization (NDA) to the Ministry of Food and Drug Safety for the indication of benign masseteric hypertrophy for Nabota, a self-developed botulinum toxin preparation.
This submission was made based on the results of a phase 3 clinical trial conducted on 180 adults in need of improvement in benign masseteric hypertrophy (square jaw).
The trial was conducted in a double-blind manner in which efficacy and safety were evaluated every 4 weeks for a total of 24 weeks after one dose of Nabota or placebo was randomly assigned.
It was confirmed that the average change in the thickness of both masses at the maximum occlusion at 12 weeks after administration, the main endpoint, decreased by more than 20% compared to the baseline before administration. This was a result of more than 7-fold reduction compared to the placebo group.
In this clinical trial, more than 80% of subjects responded that they were satisfied, and no serious adverse events related to the drug were reported.
In addition, Daewoong Pharmaceutical conducted an extension test to confirm the effectiveness of repeated administration.
At the 12th week after repeated administration, it was confirmed that the average change in the thickness of both masses at the maximum occlusion increased rather than the first administration.
“If we add the improvement of benign masseteric hypertrophy for the first time in the world, it will be a global No. 1 It will be botulinum toxin,” said Daewoong Pharmaceutical Vice President Park Seong-soo.
“Through synergy between Nabota and Violet, Daewoong Pharmaceutical will be reborn as a global medical esthetic company.”
Meanwhile, the global botulinum toxin market is estimated to be around $5 billion in 2020, and is expected to expand to more than $6 billion in 2023. Accordingly, the square jaw toxin treatment market is also expected to grow.
