W-17: Racial Effect Analysis in Supporting Drug Application for ST-101, A Fixed Dose Combination of Olmesartan and Rosuvastatin

Poster Presenter

Yueh Jung (Cynthia) Lee

Director of R&D
Autotelic Inc
United States

Objectives

Racial effect analysis was performed to bridge the clinical data in Korean subject to the US population, so that to support the NDA submission of ST-101, a fixed dose combination product of olmesartan medoxomil (OM) and rosuvastatin calcium (RC), for marketing approval with the US-FDA.

Method

The clinical trials on the pharmacokinetics (PK) and pharmacodynamics (PD) of ST-101 were conducted in Korean subjects. Due to the race difference in PK and PD of rosuvastain between Asian and Caucasian population, racial effect analysis was performed using data collected from published studies.

Results

Plasma exposure to olmesartan in Korean subjects treated with ST-101 is similar among Asian and non-Asian subjects. Race is not an important factor in olmesartan PD. As a result, similar PD response to olmesartan component of ST-101 is expected across Asian and non-Asian subjects in the US. Race is an important predictor of PD response for rosuvastatin calcium which is consistent with its PK. Data obtained from Korean subjects treated with ST-101 adequately predicts its effect in Asian subjects in the US, which are well understood. ST-101 PK in Korean subjects adequately predicts its PK in the US population. There is no PD interaction between olmesartan medoxomil and rosuvastatin calcium among Asian and non-Asian patients.

Conclusion

The results demonstrated that ST-101 PK and PD in Korean subjects adequately predicts its PK and PD in the US population. The racial effect analysis results were instrumental in supporting a successful EOP2 and preNDA meetings with US FDA.