Dongkook Pharmaceutical announced on the 3rd that it has received approval for the item license of the world's first improved drug for benign prostatic hyperplasia, "Uresco Tab," which combines dutasteride and tadalafil.
Benign prostatic hyperplasia is a common condition that occurs as the prostate enlarges with age, leading to various urinary function abnormalities.
Uresco Tab is an improved drug combining 0.5 mg of dutasteride and 5.0 mg of tadalafil, used to treat moderate to severe symptoms of benign prostatic hyperplasia. Clinical trial results conducted at 19 hospitals in the country demonstrated superior efficacy compared to single agents by providing a dual effect that reduces prostate size while alleviating lower urinary tract symptoms caused by benign prostatic hyperplasia. Exclusive rights are guaranteed for six years following approval.
Yoo Gi-woong, head of the development division at Dongkook Pharmaceutical, who oversaw the Uresco Tab project, noted, "Until now, the only combination drug for benign prostatic hyperplasia available in the country was GSK's DuoDart," adding, "With the approval and domestic launch of Uresco Tab, patients will have a wider range of treatment options." He stated, "Preparations for entering the global market will also proceed alongside the domestic launch." The global market for drugs treating benign prostatic hyperplasia is approximately 17 trillion won as of 2024.
Kim Cheong-soo, a professor of urology and head of the Prostate Cancer Center at Ewha Womans University Medical Center, who oversaw the Phase 3 trial, explained, "The combination drug showed superior improvement over single agents in terms of the International Prostate Symptom Score (IPSS), and there was no statistically significant difference in adverse drug reactions between the combination and single agents." Professor Kim stated, "This will greatly help in the treatment and quality of life improvement for patients with benign prostatic hyperplasia."
In the development of this combination drug, Dongkook Pharmaceutical collaborated with DongKoo Bio&Pharma, Dong-A ST, and Shin Poong Pharm. Dongkook Pharmaceutical will be responsible for the production of Uresco Tab and the products approved simultaneously with it.