South Korea’s Daewoong Pharmaceutical said Wednesday that it has promoted the safety and efficacy of its botulinum toxin product Nabota that is approaching US approval during IMCAS Asia 2018, an annual aesthetic surgery and cosmetic dermatology conference, held in Bangkok, Thailand.
At the conference, dermatology professionals who had taken part in the clinical trials for Nabota held in the US, Europe and Canada stressed how Nabota has strong clinical evidence proving its efficacy and safety, according to the Korean drugmaker.
Daewoong’s IMCAS presentation comes as the Korean drugmaker prepares to launch its Type A botulinium toxin Nabota to major global markets, seeking approval by regulators in the US, Canada and Europe.
In June, Daewoong said it had received Good Manufacturing Practice certification from the European Medicines Agency for its production site in Gyeonggi Province. Now, Nabota only has to clear marketing authorization from the EMA to start sales in Europe.
The US is another major market targeted by the Korean drugmaker. Daewoong, together with its US partner Evolus, submitted a biologics license application for Nabota to the US FDA in May 2017, with aims to commercialize the drug in the US by the end of 2018.
However, the US FDA rejected its application by issuing a complete response letter in May, citing deficiencies related to the chemistry, manufacturing and controls processes, delaying the drug’s entry to the US.
Despite the dampened outlook, the companies have cited plans to soon refile an application with supplementary documents, with the aim of obtaining the US regulator’s final marketing approval by next year.
If approved as planned, Nabota is expected to become the first Korea-made BTX to enter the US. And industry analysts expect Evolus to aggressively market the drug at a steep discount and reap benefits from being the only company to sell a Type A BTX drug at cheaper prices.
By Sohn Ji-young (
jys@heraldcorp.com)