J&J, Amgen drugs again under FDA scan

J&J and Amgen have been continuously facing trouble over their anemia drugs. FDA is now reviewing two latest studies which provide evidence that J&J’s Procrit and Amgen’s Epogen and Aranesp are more seriously related to risks for some cancer patients treated with these medicines.

Earlier in November, FDA had asked the companies to add additional labels saying that if these drugs are overused then they can increase the risk to diseases especially in cancer patients. It also stated that the risk is substantial for cancer patients even at the doses which were considered safe earlier, but the conformation was held till results of further studies arrived.

These drugs are used to treat the blood-disorder anemia in kidney-failure and chemotherapy patients and belong to a class known as Erythropoiesis-stimulating agents or ESA’s. ESA’s help in the formation of red blood cells as these biologically engineered proteins similar to the ones in kidney which cause bone marrow to produce RBC’s.

The two latest studies were conducted on the women who were suffering from Breast and Cervical cancer. The Prepare study, conducted by Amgen enrolled women who received chemotherapy before breast-cancer surgery. 14% breast cancer patients who were treated with Amgen’s drug Aranesp died after three years, compared with just 9.8 percent of patients not taking the drug.

A separate study called GOG-191, dealt with women receiving chemotherapy and radiation for advanced cervical cancer and it was found that only 58% of patients, who were taking Johnson & Johnson's Procrit, were alive and free of cancer as compared to 66% patients, who did not take the drug.

The findings are "consistent with previous data on tumor growth and death" and will be discussed with a committee of outside advisers at a public meeting in the next few months, an FDA statement said.

"FDA recommends that health care providers review the risks and benefits of" the drugs, said FDA Deputy Commissioner Janet Woodcock.

Amgen promised its full support to further studies and said that it was concerned about the patient safety and was working with FDA to make appropriate amendments.

J&J however said that “the studies showed a numerical trend toward shorter survival in patients treated with the anemia drugs. But neither showed a statistically significant difference in survival or tumor growth, which means the findings, could have been due to chance.”

Amgen depends a lot on the sales of this drug whereas J&J are not that dependent. Amgen reaped $6.6 billion, or nearly half of its sales, from Aranesp and Epogen in 2006. Epogen is used for treating anemia in kidney failure patients undergoing dialysis. However, the sales have decreased in 2007 because of safety concerns.

Amgen shares fell nearly 2 percent on Nasdaq to close at $45.69, touching a 5-year low during the day. Johnson & Johnson shares however gained 2 cents to close at $65.93 on the New York Stock Exchange.