"To Become the Leading Toxin for Facial Procedures"
Daewoong Pharmaceutical's botulinum toxin (BTX) product Nabota has become the world's first to add the indication for square jaw.
On the 25th, Daewoong Pharmaceutical announced on the 27th that Nabota, its BTX product, received approval from the Ministry of Food and Drug Safety for the indication of benign masseter hypertrophy (square jaw). With this new indication approval, Nabota now holds a total of five indications. In the aesthetic field, it has added the square jaw indication following frown lines and crow's feet, and in the therapeutic field, it holds indications for post-stroke upper limb spasticity and blepharospasm.
The square jaw indication for Nabota obtained by Daewoong Pharmaceutical is the first indication of its kind among BTX products worldwide. The company explained that Nabota has become the only product with indications for major treatment areas in both the upper and lower face, thereby significantly strengthening its competitiveness in facial procedures.
In a phase 3 clinical trial for the square jaw indication conducted at Chung-Ang University Hospital and Konkuk University Hospital, Daewoong Pharmaceutical administered Nabota to 180 adults and compared the average change in bilateral masseter thickness at maximum bite force at 12 weeks post-injection. The results showed about a sevenfold reduction compared to the placebo group. No safety concerns were observed.
Detailed clinical results confirmed statistical significance in all efficacy evaluations, including the average change and rate of change in bilateral masseter thickness at maximum bite and at rest compared to baseline, average change rate of lower facial volume at rest through 3D facial contour analysis, and patient satisfaction. Additionally, over 80% of subjects reported satisfaction at the time of maximum effect, and no serious drug-related adverse events were reported. Daewoong Pharmaceutical conducted an extension study to verify efficacy upon repeated administration and confirmed that the average change in bilateral masseter thickness at maximum bite at 12 weeks after repeated administration was even greater than after the first administration.
Daewoong Pharmaceutical plans to leverage this new indication approval to add the square jaw indication to Nabota's overseas approvals, aiming to establish it as a leading product for facial procedures in the global market. Furthermore, the company intends to develop combined facial treatment methods together with 'Violet,' an injection for submental fat reduction.
Park Sung-soo, Vice President of Daewoong Pharmaceutical, stated, "Nabota has strengthened its competitiveness by becoming the world's first BTX product to obtain the square jaw indication, preparing to take a step forward as the global number one botulinum toxin. Through the synergy of Violet, the only submental fat reduction injection in Korea, and Nabota, we will become a leading global medical aesthetic company."
Meanwhile, Nabota has shown an average annual sales growth rate of 62% over the past two years in the largest market, the United States, driven by strong support from the millennial generation, surpassing a 10% market share locally. In June, Nabota was launched in Italy following the UK, Germany, and Austria, expanding its influence in Europe. In 2024, it plans to launch in Australia to broaden its market presence, and approval procedures are underway in China as well.
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