Dragon Pharmaceuticals Inc. today announced that it has submitted a New Drug Licence application to the Chinese State Drug Administration (SDA) for the use of recombinant human erythropoietin (EPO) in surgical patients. Dragon’s EPO is currently approved and marketed for use in the treatment of anemia related to chronic renal failure in China as well as in India, Egypt and Peru.
Dragon’s regulatory submission is based on the Company’s successful completion of a pivotal Phase II/III clinical trial. This multi-centre, randomized, open-label and blank-control study involved a total of 120 patients undergoing elective surgery, with 60 patients in the EPO group and 60 in the blank-control group. The primary objectives of the study were to evaluate the efficacy of EPO on increasing the production of red blood cells and correcting anemia in pre-operative and post-operative patients.
“Use of EPO for surgical indications is a key step in the development and marketing of our lead product,” said Dr. Longbin Liu, President and CEO. “With approximately 20 million surgeries performed on an annual basis in China alone, we expect the surgical indication to significantly expand our potential market in China, and eventually worldwide.
Study results showed that Dragon’s EPO resulted in red blood cell mobilization in pre-operative patients. In post-operative patients, the product increases hemoglobin, hematocrit, and red blood cell levels, thus markedly rectifying blood loss resulting from surgery. The study established that EPO is safe when used in surgical patients for red blood cell mobilization and recovery; patients experienced no increase in platelet counts or blood pressure and no changes in liver or kidney function.
In addition to seeking approval in China, Dragon plans to obtain marketing approval for the use of EPO in surgical patients throughout its licensed territories, which include over 90 countries in Central and Eastern Europe, Southeast Asia, Latin America and the Middle East. Regulatory applications for the use of EPO in anemia related to chronic renal failure are currently underway in these markets, with approvals granted to date in Egypt, India, and Peru.