Korea United Pharm applies for approval of combo drug Cilo Duo 

Korea United Pharm said it completed applying to the Ministry of Food and Drug Safety (MFDS) for the marketing authorization of Cilo Duo Tablets 200/20 mg and 200/10 mg  for treating chronic arterial occlusion in patients with hypercholesterolemia.

According to the company, Cilo Duo is indicated for improving ischemic symptoms, including ulcers, pain, and cold sensations associated with chronic arterial occlusive disease (occlusive atherosclerosis, diabetic peripheral vasculopathy) in patients taking statins. Cilo Duo combines the antithrombotic cilostazol and the dyslipidemia drug rosuvastatin.

In February last year, Korea United Pharm applied for the drug's approval. However, after an internal review by the MFDS, the company received a review opinion stating that the results of the phase 3 clinical trial were insufficient to prove final efficacy due to statistical errors. Last October, Korea United Pharm voluntarily withdrew the application to accept the review opinion and reorganize the process.

The company made the latest application for approval of Cilo Duo after revising the clinical trial report and securing additional evidence of efficacy.

The primary validity assessment of the trial results showed that the least squares mean (±SE) change in KPAQ summary score from baseline to Week 24 in the FAS arm, the primary analysis arm of the trial was 15.43 (±1.39) points in the treatment arm and 10.30 (±1.27) points in the control arm. The least squares mean difference (treatment - control) value and 95 percent confidence interval between the two treatment arms was 5.13 [1.53, 8.73], showing a statistically significant difference between treatment arms for change (p=0.0049). The two-sided confidence interval did not include zero, confirming the superiority of the study drug compared to the control arm.

In the PPS arm, the mean change (±SD) in KPAQ summary score from baseline to week 24 was 15.27 (±14.26) points in the treatment group and 10.69 (±14.52) points in the control group. The least squares mean difference (treatment - control) value and 95 percent confidence interval between the two treatment arms was 5.23 [1.58, 8.88], showing a statistically significant difference between the treatment arms for change (p=0.0052).

The study's rate of serious adverse events (SAEs) was 6.15 percent in the treatment arm and 5.38 percent in the control arm. According to Fisher's exact test, statistical analysis of the SAE summary for the control and study arms did not show a significant difference at p=0.1025.

“Dyslipidemia and antithrombotic agents are highly prescribed in combination in real-world practice, and dyslipidemia and peripheral arterial disease are etiologically linked,” Korea United Pharm said. “With this study demonstrating safety and efficacy in hypercholesterolemic patients with chronic arterial occlusive disease, we look forward to providing patients with a combined dyslipidemia and antithrombotic treatment option that will increase convenience and demand.”

After receiving marketing authorization, Korea United Pharm plans to launch Cilo Duo Tablets in the Korean market.