Daewoong Pharmaceutical Applies for Approval of Botulinum Toxin 'Nabota' for Square Jaw Indication

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[Asia Economy Reporter Lee Gwan-joo] Daewoong Pharmaceutical announced on the 21st that it has submitted a New Drug Application (NDA) for the botulinum toxin product ‘Nabota’ for the indication of benign masseter hypertrophy to the Ministry of Food and Drug Safety.

This submission was based on the results of a Phase 3 clinical trial conducted on 180 adults requiring improvement of benign masseter hypertrophy (square jaw). The trial was conducted as a double-blind study, where Nabota or placebo was randomly assigned and administered once, followed by efficacy and safety evaluations every 4 weeks over a total of 24 weeks.

The primary endpoint confirmed a reduction of more than 20% from baseline in the average thickness change of bilateral masseter muscles at maximum clenching at 12 weeks post-administration, which was more than seven times greater than the placebo group. Additionally, statistical significance was confirmed in all evaluation variables, including the average change and rate of change in bilateral masseter thickness at maximum clenching and at rest at each evaluation point compared to baseline, average change rate of lower face volume at rest through 3D facial contour analysis, and patient satisfaction. Over 80% of subjects reported satisfaction, and no serious adverse drug reactions were reported, according to the company.

Furthermore, an extension study was conducted to confirm efficacy upon repeated administration, which showed that the average thickness change of bilateral masseter muscles at maximum clenching at 12 weeks after repeated administration increased in effect compared to the first administration.

Park Sung-soo, Vice President of Daewoong Pharmaceutical, said, “If we add the indication for benign masseter hypertrophy improvement as the world’s first, we will take a step closer to becoming a botulinum toxin with various aesthetic indications,” and added, “Through the synergy of Nabota and Violette, an injection for submental fat improvement, we will become a leading global medical aesthetic company.”

Nabota is the first product in Asia to receive FDA approval in the United States and currently holds four indications: glabellar lines, upper limb spasticity after stroke, crow’s feet, and blepharospasm. Daewoong Pharmaceutical is currently conducting clinical trials for cervical dystonia and migraine with approval from the U.S. Food and Drug Administration (FDA).

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