Daewoong Pharmaceutical’s botulinum toxin Nabota is expected to hit the US market by the end of 2018, fueling competition among rivals amid a near monopoly of Allergan.
The Korean drug maker’s US distribution partner Alphaeon said on May 17 it submitted a biologic license application for the Botulinum toxin Type A, with the US Food and Drug Administration seeking approval for the treatment of adult patients with frown lines. It generally takes about a year to clear the regulatory hurdle.
“Submission of the BLA within three years of the first study enrollment speaks of our experience, drive and commitment. We are excited to move one step closer to its commercial launch,” Chris Marmo, president of Beauty for Alphaeon, said in a press release.
According to the California-based biotech firm, a total of 1,500 adult male and female subjects participated in phase 2 and 3 clinical programs of the wrinkle smoother.
If successful, Nabota will be the first botulinum toxin developed by a Korean company to enter the US while other local peers like Hugel and Medytox are gearing up to make inroads into the world‘s largest botulinum toxic market.