FDA says more action possible on J&J, Amgen drugs

Reuters - January 3, 2008

FDA says more action possible on J&J, Amgen drugs

By Lisa Richwine

WASHINGTON (Reuters) - U.S. regulators said on Thursday they were reviewing two recent studies that provided more evidence of serious risks for some cancer patients treated with anemia drugs sold by Amgen Inc and Johnson & Johnson.

The Food and Drug Administration "is reviewing these data and may take additional action," FDA Deputy Commissioner Janet Woodcock said in a statement.

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

In the studies, researchers used Amgen's Aranesp or J&J's Procrit to drive a patient's level of oxygen-carrying hemoglobin to 12 grams per deciliter or higher, although many patients did not reach that level. Current warnings on the drugs say hemoglobin levels should not rise above 12 for patients with cancer.

The FDA said the studies found patients with breast or advanced cervical cancer who were treated with the medicines died sooner, or had more rapid tumor growth, than similar patients who were not given the drugs.

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.

The companies had disclosed results from the studies, known as GOG-191 and Prepare, in November and December. The FDA had approved stronger warnings on the anemia drugs earlier in November.

The Prepare study enrolled women who received chemotherapy before breast-cancer surgery. The FDA said that after three years, 14 percent of patients treated with Aranesp had died, compared with 9.8 percent who did not get the drug.

In GOG-191, researchers studied women receiving chemotherapy and radiation for advanced cervical cancer. After three years, 66 percent of patients who did not take Procrit were alive and free of cancer growth, compared to 58 percent who had received the drug, the FDA said.

Ortho-Biotech, the J&J unit that sells Procrit, said on Thursday 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, the company said in a statement.

Amgen said on Thursday it was working with the FDA on updates to the anemia drug labels because the company was "concerned about patient safety."

The anemia drugs are erythropoiesis-stimulating agents, also known as ESAs or Epo drugs. They are man-made versions of a natural protein that stimulates production of red blood cells.

Amgen also sells an ESA called Epogen for treating anemia in kidney failure patients undergoing dialysis.

Amgen reaped $6.6 billion, or nearly half of its sales, from Aranesp and Epogen in 2006, but use fell sharply in 2007 amid safety concerns. J&J is less reliant on Procrit sales.

(Reporting by Lisa Richwine, editing by Dave Zimmerman and Carol Bishopric)

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