A new FDA-mandated risk management program charges Amgen with responsibility for apprising doctors and patients of the pitfalls and benefits of treating chemotherapy-related anemia with some of its best-selling drugs. The drugs, sold as Epogen and Aranesp, brought in $5.8 billion in sales to Amgen in 2009 . Together with Procrit, which is sold by Johnson & Johnson, the drugs are known as known as erythropoiesis-stimulating agents and help alleviate anemia by stimulating bone marrow to make red blood cells.

 

The FDA announcement carried little shock value for investors, since the risk-awareness program has been in development since April 2008. Nonetheless, it will carry serious new responsibilities for Amgen. The company must now ensure doctors complete a special training program on how to use ESAs in patients with cancer. It also has to ensure patients receive a medication guide about ESAs and that doctors get signature-proof from their cancer patients stating they have discussed the risks and benefits of ESAs before treatment.

 

“This new risk management program will help ensure that patients and their health care professionals have fully considered the benefits and risks of using ESAs,” says Richard Pazdur, director of the Office of Oncology Products in the FDA’s Center for Drug Evaluation and Research.

 

Sales of Aranesp have been in decline ever since the FDA initially issued safety warnings about the ESAs in 2007, flagging their potential for accelerating tumor growth and increasing the risk of serious heart problems such as heart attacks, heart failure and strokes. Global sales of the drug were down 15 percent in 2009, "primarily due to a decline in U.S. demand reflecting the product label change," says Amgen.

 

Sales of J&J's Procrit, which is manufactured by Amgen, also declined 12 percent during the the first 9 months of 2009, the most recent period for which figures are available.

 

Epogen sales actually grew five percent in 2009, but that growth was mostly due to patient population growth, increased dose utilization and an increase in average net sales price, according to Amgen.

 

Although ESAs are also approved for the treatment of anemia related to kidney failure, the program will not apply to doctors using ESAs for that purpose.