Daewoong Pharmaceutical announced on the 9th that AEON Biopharma, a partner in the botulinum toxin treatment business, has been approved by the US Food and Drug Administration (FDA) for phase 2 clinical trials for migraine prevention and started recruiting patients.
Ion Biopharma is scheduled to conduct clinical trials in the United States, Canada, and Australia in 690 adult patients with migraine headaches for more than 6 days a month.
This clinical trial aims to secure the effect of prophylactic treatment for chronic migraine (Chronic Migraine), which suffers from headache symptoms more than 15 days a month, and episodic migraine (Episodic Migraine), which has symptoms less than 15 days a month.
In particular, the indication for episode migraine is the first case that none of the existing global botulinum toxin products have been secured.
Migraine is one of the most common diseases in the world, affecting about 40 million people in the United States and about 1 billion people worldwide. It is estimated that about 2.2 million people have chronic migraine in the United States, and far more people suffer from episode migraine.
Ion Biopharma is an exclusive partner company that has the right to license, import, and sell Daewoong Pharmaceutical’s botulinum toxin formulations for therapeutic purposes in the US, Europe, and Canada. Starting with Cervical Dystonia, which was approved for phase 2 clinical trials last year, clinical trials for treatment indications will be initiated, and additional indications for the treatment of chronic diseases will be continuously acquired.
“The botulinum toxin treatment market occupies more than twice the beauty market and has a very high growth potential,” said Park Seong-soo, head of Daewoong Pharmaceutical’s Nabota Business Division. Botulinum Toxin Jubo (Jeuveau) manufactured by Evolus and sold by its partner, Evolus, has already been approved by the US FDA and European EMA as an indication for glabellar wrinkles. “I said.
He predicted that “in the future, we will be able to cooperate with our partner, Aeon Bio Pharma, to provide excellent products at reasonable prices to US patients, and to raise the status of K-Bio.