Jeil applies for product permit for new overactive bladder treatment

Jeil Pharmaceutical said Friday it has applied for approving Beova (ingredient: vibegron), a new drug for overactive bladder.

Beova is a new drug for treating overactive bladder developed by Kyorin Pharmaceuticals in Japan. Jeil completed a phase 3 bridging clinical trial before applying for approval.

The bridging study compared the safety and efficacy of Beova in 210 overactive bladder patients at 20 medical institutions, including Asan Medical Center. The company confirmed that the change in the average daily urination frequency at 12 weeks compared to the baseline improved to -2.38 compared to -1.22 for placebo.

Beova showed significant improvement compared to placebo in the secondary endpoints, including the average number of urgency to urinate per day, the number of urgent urination, the change in the number of incontinence, and the change in the average urination per day. In the safety evaluation, the incidence of adverse reactions was similar to that of a placebo, confirming the safety of the treatment.

Last year, the company also conducted a successful phase 1 clinical trial for direct in-house production before applying for the drug approval. If the Ministry of Food and Drug Safety approves the drug, Jeil plans to manufacture and supply the drug in Korea.

“As the company confirmed encouraging therapeutic efficacy through bridging clinical trials, it plans to commercialize it and quickly enter the bladder treatment market,” a company official said. “The company also plans to expand indications, such as improving overactive bladder symptoms in benign prostatic hyperplasia (BPH) patients.”