Amgen Gets FDA Approval for Drug

Amgen Inc. won Food and Drug Administration approval of a longer-acting version of Neupogen, its $1-billion blockbuster chemotherapy drug.

Neupogen is used daily during chemotherapy to prevent a drop in infection-fighting white blood cells. The new form, to be sold as Neulasta, can be taken once during a chemotherapy cycle, which is typically three to four weeks, the company said. Neulasta is designed to prevent infection as well as treat it.

The new medicine’s volume allows the drug to circulate longer in the bloodstream before being removed by the kidneys. A.G. Edwards & Sons Inc. analyst Craig West said the medicine, also called pegfilgrastin, may give a modest boost to Neupogen sales. Neupogen had $1.3 billion in sales in 2001, according to Amgen.

Shares of Thousand Oaks-based Amgen rose 46 cents to close at $55.50 on Nasdaq, before the news was announced.