Daewoong Pharmaceutical Botulinum Toxin 'Jubo', Safety and Efficacy of Repeated Administration Confirmed

[Asia Economy Reporter Chunhee Lee] Research results on the safety and efficacy of repeated administration of Daewoong Pharmaceutical's botulinum toxin 'Jubo' (the US launch name of Nabota) have been announced.

On the 14th, Daewoong Pharmaceutical reported that two follow-up study papers on the Phase 2 clinical trials of Jubo conducted in the US, Canada, and Europe were published in the SCI international journal 'Aesthetic Surgery Journal'.

Daewoong Pharmaceutical's US partner, Evolus, conducted a one-year follow-up observation on patients from the existing Phase 2 clinical trials to investigate the efficacy in improving glabellar lines and the safety of repeated administration of Jubo. The study involved administering Jubo to patients aged 18 or older with moderate to severe glabellar lines and assessing wrinkle improvement using the 4-point Glabellar Line Scale (GLS) at certain time points. If the GLS score was 2 points or higher when frowning maximally after 90 days, Jubo was re-administered.

The study results showed that in two clinical trials (EV-004, EV-006), the proportion of patients reporting at least a 1-point improvement in the 4-point GLS at 30 days after repeated treatment was 94.1% and 96.4%, respectively. Additionally, both trials showed that the interval between repeated treatments did not shorten but tended to increase, confirming that the effect was continuously maintained.

Adverse effects decreased with repeated administration. Drug-related adverse events were 11.1% and 10.7% in EV-004 and EV-006, respectively. However, with repeated administration, only 1.7% and 1.4% showed drug-related adverse reactions. There were no serious drug-related adverse reactions, and among a total of 6,453 samples, no neutralizing antibodies that could cause resistance were detected.

Botulinum toxin requires administration not just once but periodically over the long term. Research results on potential efficacy reduction or adverse effects from repeated administration are important. A Daewoong Pharmaceutical official evaluated, "Through this large-scale clinical trial, we have proven the safety and sustained efficacy of repeated administration of Jubo."

Park Sung-soo, Head of the Nabota Business Division at Daewoong Pharmaceutical, said, "The excellence of Jubo has been proven once again through this research result," and added, "We will continue to strengthen the position of Daewoong Pharmaceutical's botulinum toxin products and elevate the global status of K-bio."