U.S. advisers: Restrict Amgen, J&J anemia drugs

By Lisa Richwine and Kim Dixon

GAITHERSBURG, Maryland (Reuters) - The widespread use of anemia drugs sold by Amgen Inc (AMGN.O) and Johnson & Johnson (JNJ.N) should be sharply restricted for cancer patients amid serious safety concerns, a U.S. advisory panel said on Thursday.

The Food and Drug Administration panel recommended against giving the medicines to patients with potentially curable cancers who are undergoing treatment, or to patients with advanced breast cancer or head and neck cancer.

"How long do patients have to continue to be exposed to a drug that we are not sure is safe?" said Dr. Judith Kramer of Duke University and a panel member.

The FDA typically takes the advice of its expert panels.

The recommendations come after eight studies found evidence of tumor growth or shorter survival for some patients given high doses of the drugs, which include Amgen's top-selling product Aranesp and J&J's Procrit.

Tens of thousands of cancer patients take the drugs for anemia caused by chemotherapy. Anemia, or low levels of red blood cells, causes fatigue and weakness.

The drugs, known as erythropoiesis-stimulating agents (ESAs), are genetically engineered forms of a protein that boosts production of red blood cells. The injectable medicines also are sold for patients with kidney disease.

The panel rejected, in a 13-1 vote, a more extreme option of recommending a complete withdrawal of all approved uses for cancer patients.

Amgen shares, which had been pressured by concerns about the panel meeting, closed 4.9 percent higher at $47.18 on Nasdaq after the panel decision.

Before Thursday, Amgen's shares had fallen about 20 percent since early December when the FDA panel review was announced.

Despite dodging the most extreme option, analysts said Aranesp sales could drop significantly if the FDA follows the panel's recommendations.

"They're probably losing about a third of their market" in cancer patients, said Mike King, an analyst at Rodman and Renshaw.

The panel is saying "if you want to cure a patient with chemo, don't kill them with an ESA," King said.

Other analysts said Aranesp cancer sales could drop as much as 50 percent.

Amgen issued a brief statement saying it would work with the FDA as the agency considered changes to the drug labels.