Racial Effect Analysis Using JMP in Supporting Drug Application for ST-101, A Fixed Dose Combination of Olmesartan and Rosuvastatin
Wen Wang1, Larn Hwang1, and Vuong Trieu2
1Autotelic Inc, Fountain Valley, CA, USA; 2Stocosil Inc, City of Industry, CA, USA
ST-101 is a fixed dose combination (FDC) product of olmesartan medoxomil (OM) and rosuvastatin calcium (RC) for treatment of hypertension and hypercholesterolemia. The clinical trials on the pharmacokinetics (PK) and pharmacodynamics (PD) of ST-101 were conducted in Korean population and the product has been approved by Korean FDA. Due to the race difference in PK and PD of rosuvastain between Asian and Caucasian population, racial effect analysis was performed to support drug application to US FDA. The PK, PD data of OM and RC were collected from published clinical studies. ST-101 clinical data were compared with the published clinical data of OM and RC in Asian and non-Asian subjects using JMP software. Dose, race and body weight were used as covariates, and the number of subjects in each study was used as weighing factor in the analysis using Fit Model function in JMP. 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 meeting with US FDA, who has agreed that the clinical data in Korean may be sufficient for a new drug application submission.