[Daewoong Pharmaceutical Nabota] Expanding to 5th indication for Botulinum toxin

‘Nabota’, a botulinum toxin developed independently by Daewoong Pharmaceutical, is striding towards its fifth indication. Currently, ‘Nabota’ has 4 indications in the cosmetic area including glabellar line, upper extremity muscle stiffness after stroke, wrinkle around the eyes and eyelid spasm.

The fifth indication that Daewoong is expanding to this time is the ‘square jaw (benign masseteric hypertrophy).

Previously, Daewoong Pharmaceutical submitted an application for new drug indication approval (NDA) to the Ministry of Food and Drug Safety in April.

‘Nabota’ is undergoing phase 2 clinical trials for cervical dystonia, and chronic and episodic migraine through U.S. partner Ion Biopharma upon approval by the U.S. Food and Drug Administration (FDA).

In 2020, as ‘Nabota’ was clinically proven to be effective in the treatment of male pattern hair loss, it was published in the December issue of Journal of the American Academy of Dermatology (JAAD), an SCI journal.

Following the square jaw, there is a possibility that 'Nabota' expands to more than 8 indications in total at present, including cervical dystonia, chronic and episodic migraines, and male pattern hair loss.

The fifth indication was based on the results of a phase 3 clinical trial conducted on 180 adults who needed improvement in the square jaw. The clinical trial was conducted in a double-blind method, in which efficacy and safety were assessed every 4 weeks for a total of 24 weeks after a single dose of Nabota or placebo was administered in a random allocation.

The results confirmed that the average change in the thickness of both masseteric masses at the maximum occlusion at 12 weeks after administration, the main endpoint, decreased by more than 20% compared to the baseline, which was a decrease of more than 7 times compared to the placebo group.

Also, in the extension study to verify the effectiveness of repeated administration, it was confirmed that the effect increased compared to the first administration in the average change in the thickness of both masseteric masses at the maximum occlusion at 12 weeks after repeated administration.

The global botulinum toxin market has a market size of over $5 billion as of 2020, and is expected to grow to more than $6 billion in 2023. Subsequently, the market for toxin treatment of the square jaw is also expected to grow.

As of the first quarter of this year, the sales of Nabota were recorded at 30.7 billion won, a 98% increase from 15.4 billion won year-to-year. Exports rose by 189% from 7.9 billion won to 22.8 billion won in the same period of last year.

An official from Daewoong Pharmaceutical said, “We submitted an application for biologics license to the Chinese National Drug Administration at the end of last year and are expecting to obtain approval within 2022 at the earliest.”

[WIKI KOREA=Kim Sun, Reporter]