FDA Panel OKs New Use for Amgen’s Neupogen

Amgen Inc. in Thousand Oaks has won the backing of an expert government panel to expand the use of its Neupogen immune-system drug to include treatment of patients with a form of leukemia.

A Food and Drug Administration advisory committee voted unanimously to recommend that the agency approve the drug for patients with acute myelogenous leukemia. The FDA generally follows the advice of its expert committees.

“It was a well-designed trial and clearly demonstrated effectiveness,” said panel chairwoman Julie Voss. Voss called the extent of the drug’s effect “impressive.”

FDA approval for treating low white-cell counts in patients with acute myelogenous leukemia would be the fifth approved use for Neupogen.

Acute myelogenous leukemia is a cancer in which abnormal or immature white blood cells crowd out the red platelet blood cells produced in the bone marrow. The chemotherapy and radiation used to treat the condition leave the patient with virtually no immune system.

Neupogen has been shown to stimulate the production of healthy immune cells.

An expanded approval of the drug, which had sales of $1 billion last year and makes up about half of Amgen’s sales, would be important to the firm as it struggles to maintain its post as the leading biotech company.

Amgen announced in June that it expected slower sales for its other star drug--Epogen--after a government group announced it would reduce Medicare payments for the drug.