The Food and Drug Administration will require Biotech giant Amgen to implement a risk management program designed to warn physicians and patients about the risks and benefits of using its blockbuster drugs, Epogen and Aranesp to treat chemotherapy-related anemia.
The drugs, which are known as erythropoiesis-stimulating agents, help mitigate anemia in cancer patients by stimulating bone marrow production of red blood cells
The new FDA regs require Amgen to assure that physicians complete training designed to teach them how best to use ESAs in cancer patients. Amgen must also assure that patients get a medication guide about the drugs, and that both doctors and patients must sign a form indicating that risks and benefits of ESAs have been discussed prior to treatment.
“This new risk management program will help ensure that patients and health care professionals have fully considered the benefits and risks of using ESAs,” Richard Pazdur, director of the Office of Oncology Products in the FDA’s Center for Drug Evaluation and Research told BurrillReport.
Epogen and Aranesp netted $5.8 billion in sales for Amgen last year, which is down nearly 15% year over year. The sales falloff actually began in 2007, when the FDA first issued safety warnings about the ESAs. The warnings suggested that ESAs may accelerate tumor growth and increase the risk of cardiovascular complications like heart attacks and strokes.
ESAs are FDA-approved for anemia associated with kidney failure, but the new program does not apply to that patient population.