UPDATE 1-Europeans to tighten guidelines on anemia drugs
(Updates with details)
BOSTON, Sept 27 (Reuters) - Amgen Inc. (AMGN.O) said on Thursday that European regulators intend to require makers of certain anemia drugs, including Amgen's Aranesp, to amend their prescribing guidelines.
The European Medicines Agency's Committee for Medicinal Products for Human Use has put forward a proposal that will limit prescribing of the drugs, which include Johnson & Johnson's (JNJ.N) Procrit, to patients whose hemoglobin levels fall below 12 grams per deciliter of blood.
The agency also recommended amending the special warning section to show that clinical trials have shown an unexplained increase in death when hemoglobin levels rise higher than 12 grams per deciliter.
Amgen, the world's biggest biotechnology company, said the amendments are not final and the company will continue discussions with the agency to finalize the language and update the product label accordingly. Final prescribing information is expected in early 2008.
The proposed restrictions are slightly less onerous than those applied by U.S. regulatory bodies, and Amgen's shares stayed steady at $56.13 in mid-morning trading on Nasdaq.
In July, the U.S. Centers for Medicare & Medicaid Services, or CMS, said it would restrict payment for erythropoietin-stimulating agents such as Aranesp to patients whose hemoglobin levels fell below 10 milligrams per deciliter or lower.
Aranesp is approved to treat anemia associated with chemotherapy and kidney disease, and in 2006 generated sales of $4.1 billion. But sales have fallen amid concerns that so-called EPO drugs may increase the risk of heart attack and stroke.
EPO drugs are man-made versions of the hormone erythropoietin that stimulate production of oxygen-carrying red blood cells.
In March the U.S. Food and Drug Administration placed its strongest warning on the label of such drugs.
