New York Times, Sept 12, 2007 (Anemia Drugs)

[BobT1939]

Entire story longer but this gets across the basic idea./bobt



By ANDREW POLLACK
Published: September 12, 2007
A federal advisory committee voted yesterday against imposing a new restriction on the use of anemia drugs to treat patients with kidney disease, offering a rare reprieve to Amgen, the manufacturer of the drugs.

The panel, advising the Food and Drug Administration, voted 14-to-5 against an F.D.A. proposal to set a fairly specific upper range on the drugs’ use. Several studies have linked overuse of the drugs to cardiovascular problems and deaths and, when used to treat cancer patients, to a worsening of tumors.

Shares of Amgen, which had fallen sharply since safety concerns about the drug intensified in January, shot up more than 5 percent yesterday, closing at $53.88. The vote was also considered important to kidney dialysis chains like DaVita and Fresenius that, under Medicare rules, profit from the use of the anemia drugs.

[okarol]

Panel votes 'no' on drug limit in non-dialysis

Wednesday, September 12, 2007
REUTERS

GAITHERSBURG, Md. -- An expert advisory panel to the Food and Drug Administration voted yesterday to reject a target hemoglobin level for kidney-disease patients not on dialysis.

The action was a boost for drugmakers Amgen and Johnson and Johnson, which had urged a more liberal approach to treatment.

The FDA advisers voted against setting a limit for targeted hemoglobin of 11 grams per deciliter for Amgen's Aranesp and Epogen and Johnson & Johnson's Procrit for patients with chronic kidney failure who are not on dialysis.

Earlier, the panel voted against a strict target of about 11 for kidney disease patients on dialysis, the process of clearing waste from the blood in these patients.

The meeting comes amid concerns high doses of the drugs lead to increased risk of heart problems and even death.

The FDA usually takes the advice of its expert panels.

The anemia drugs are members of a family called erythropoiesis-stimulating agents, also known as EPO drugs.

The FDA asked the advisory panel whether the labels on the drugs -- man-made forms of a protein that boosts red blood cell production -- should specifically target an oxygen-carrying hemoglobin level in the blood.

Representatives of Amgen, the world's biggest biotechnology company, said there were serious risks for patients when their hemoglobin levels were driven too high.

But when used appropriately, the drugs can allow patients to avoid blood transfusions to correct anemia, a common side effect of kidney failure, Amgen said.

The medicines provide "a clear reduction in burden and risk of transfusions. This is unquestioned," Preston Klassen of Amgen's global development division, told the panel.

J&J unit Ortho Biotech said in a statement Procrit provided "clear clinical benefit."

Medicare, which covers 43 million elderly and disabled Americans, has sharply cut payments for Epo drugs.

Aranesp and Epogen had combined 2006 sales of $6.6 billion, nearly half of Amgen's total sales for the year. Procrit is less important to J&J, a health care products conglomerate.

The panel's vote also could impact Roche's ability to launch its anemia medicine Mircera, which is in the same class as Procrit and Aranesp.

In May, regulators gave Roche conditional approval to market Mircera pending the advisory committee's recommendations on the use of the drugs.

"Roche hopes today's frank discussion will lead to greater clarity on the appropriate use and role of these treatments and their benefits to patients with chronic kidney disease," a company spokeswoman said in an e-mail yesterday.

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