UPDATE 2-US advisers against anemia drug restrictions
(Recasts with panel vote, adds quotes, stock reaction)
By Kim Dixon and Lisa Richwine
GAITHERSBURG, Md Sept 11 (Reuters) - A U.S. panel of health experts gave Amgen Inc (AMGN.O) and Johnson & Johnson (JNJ.N) a win on Tuesday when they declined to recommend restrictions on the use of their anti-anemia drugs in kidney disease patients.
The news sent shares in Amgen, which reaps about half of its annual sales from anti-anemia drugs, sharply higher.
The Food and Drug Administration advisers voted 14-5 against setting an upper target for boosting oxygen-carrying hemoglobin for Amgen's Aranesp and Epogen, and Johnson & Johnson's Procrit, in patients with chronic kidney failure.
The meeting comes amid several studies suggesting high doses of the drugs lead to increased risk of heart problems and even death.
Sales of the three drugs, also given to cancer patients, topped $10 billion last year but have fallen in recent months amid safety concerns for their use in both patient groups.
The FDA usually takes the advice of its expert panels and officials said after the meeting it would make a decision about changes to the drugs' labels within weeks.
The agency asked the 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.
The panelists voted against the upper limit of 11 grams per deciliter of blood. Amgen backs an upper limit of 12 grams.
Panel members said the data was inconclusive about the ideal hemoglobin target and choose to err on the side of giving doctors more discretion to manage individual patients.
"I don't think we have any data to decide if the upper end of the target should be 11 or 12," said Lawrence Hunsicker of the University of Iowa Hospitals and Clinics.
AMGEN STOCK GETS A BOOST
Shares in Amgen closed up 5.6 percent, or $2.84, at $53.88 on the Nasdaq, while J&J's stock inched up 21 cents, or 0.3 percent, to $62.05 on the New York Stock Exchange.
"The market's reflecting that it was positive, and I think that's right. It seems like Amgen dodged a bit of a bullet. It could have been a lot worse," said Chris Raymond, analyst at Robert W. Baird & Co.
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 anemia drugs are members of a family called erythropoiesis-stimulating agents, also known as ESAs or Epo drugs.
Several recent clinical trials have found more deaths, heart attacks, strokes, heart failure and blood clots when high doses were given to kidney failure patients.
An FDA staff member in a presentation had argued the ideal hemoglobin target is 10 grams, plus or minus one gram, for patients on dialysis, and 11.3 in pre-dialysis renal patients.
Representatives of Thousand Oaks, California-based Amgen, the world's biggest biotechnology company, agreed 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," Dr. Preston Klassen of Amgen's global development division, told the panel.
A "black box" warning already advises doctors to give the lowest doses the drugs needed to avoid blood transfusions. It also warns about the risk of death and serious cardiovascular problems should hemoglobin top 12 grams per deciliter.
An FDA advisory panel that met in May urged limits on the drugs' use in cancer patients and more study of risks.
Medicare, which covers 43 million elderly and disabled Americans, has sharply cut payments for Epo drugs. (Additional reporting by Lisa Baertlein in Los Angeles, andRansdell Pierson and Bill Berkrot in New York, and Lisa Richwine in Washington)
