Daewoong Pharmaceutical has added benign masseteric hypertrophy (BMH), commonly known as the square jaw, to the indications for its botulinum toxin  (BTX) product, Nabota. It is the first case among BTX products worldwide to win the indication for BMH, the company said.

Daewoong said it received the Ministry of Food and Drug Safety approval last Friday. The approval comes 16 months after the company applied to the ministry in April 2022 to add the indication to improve the square jaw.

As a result, Nabota now has five indications. In the beauty field, it added the indication of a square jaw after frown lines and crow's feet in the corner of the eye. In the treatment field, it has indications for upper limb muscle stiffness after stroke and eyelid spasms.

Daewoong plans to use this opportunity to add the square jaw indication to Nabota's overseas licensees, making the product a leader in the global facial procedure market. In addition, the company plans to develop a combined facial procedure method with V-OLET, an injection for fat improvement under the chin, so that medical professionals and patients can experience satisfactory treatment results.

In a phase 3 clinical trial for Nabota’s square jaw indication conducted at Chung-Ang University Hospital and Konkuk University Medical Center, Daewoong demonstrated Nabota’s superiority by comparing the mean change in bilateral occlusal muscle thickness at maximum occlusion at 12 weeks after treatment in 180 adults and confirming a seven-fold reduction compared to the placebo group.

Daewoong demonstrated statistical significance for all efficacy endpoints, including maximum occlusion, mean change in bilateral occlusal thickness and mean rate of change from baseline to each endpoint, mean change in lower face volume, and subject satisfaction using three-dimensional facial contour analysis.

At the time of maximum effect, more than 80 percent of subjects were satisfied, and no serious adverse events were reported.

Daewoong added that it conducted an extension study to confirm the efficacy of repeated dosing and found that the mean change in bilateral occlusal muscle thickness at maximum occlusion at 12 weeks after repeated dosing was increased compared to the first dose.

"Nabota is ready to take another step forward as the global No. 1 BTX by strengthening its competitiveness through obtaining the world's first square jaw indication," Daewoong Pharmaceutical Vice President Park Sung-soo said. "Through the synergy of V-OLET, the only submental fat improvement injection in Korea, and Nabota, Daewoong will become a global leader in medical aesthetics."

Meanwhile, Huons Biopharma received the ministry’s approval for a phase 3 clinical trial for the square jaw indication of its BTX brand Liztox this past March.