Alphaeon submits BLA for Daewoong botulinum toxin

Alphaeon announced that it has submitted a BLA (biologic license application) for the Daewoong Botulinum toxin Type A, with the USFDA seeking approval for the treatment of adult patients with frown lines. It generally takes about a year to clear the regulatory hurdle so, Daewoong Pharmaceutical’s botulinum toxin Nabota is expected to hit the US market by the end of 2018.

Alphaeon president of Beauty, Chris Marmo said that submission of the BLA within three years of the first study enrollment speaks of their experience, drive and commitment. They are excited to move one step closer to its commercial launch.

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.

Daewoong is hoping to begin shipping Nabota to the US in the second half of 2018 after receiving the FDA’s Current Good Manufacturing Practices certification for its new plant, located in Hyangnam, Gyeonggi Province, that will produce the wrinkle treatment. The CGMPs is required for drugs and most biological products to be legally marketed in the US.