LOS ANGELES - Amgen Inc. said Monday that its new anti-anemia drug has cleared the main hurdle for European approval and could be on the market both there and in the United States by summer.

Aranesp was submitted to regulators in Europe and America in December 1999, two years after initial tests were undertaken.

Backlogs in drug approvals have the U.S. Food and Drug Administration running about six months behind its goal of getting reviews finished in a year, or six months if the drug is the first of its kind.

``We're just waiting for an answer,'' said Amgen spokesman Michael Beckerich. ``It could be any day now for the FDA.''

In the meantime, the European Committee on Proprietary Medicinal Products has considered Aranesp's safety and effectiveness and recommended its approval to the European Commission, which could give final marketing authorization in as little as 90 days.

Aranesp is a next-generation version of the company's flagship Epogen, for anemia stemming from kidney disease. Epogen accounts for 95 percent of the Thousand Oaks company's sales, which hit $3.4 billion in 2000.

Where Epogen is used at the end stage of renal disease, Aranesp can be used throughout chronic kidney disease and requires less dosage. Later this year, Amgen plans to seek FDA approval to use it to fight cancer-related anemia.

``Aranesp gives doctors and patients flexibility with their dosings,'' Beckerich said, adding that that translates into fewer doctor visits, paperwork and needles.

Aranesp stimulates bone marrow to make more red blood cells, which bring about anemia when they fall below normal levels.

Epogen was the subject of a four-year court battle between Amgen and Transkaryotic Therapies Inc. of Cambridge, Mass. Amgen, which sued for patent infringement, won the suit in January.

Once approved, Aranesp could be on the market within weeks. Launch schedules for each European Union country vary according to the nation's pricing and reimbursement procedures.

Applications for the drug were filed in early 2000 in Canada, New Zealand and Australia.

It can be beneficial to have the same drug under scrutiny in several different countries, said FDA spokeswoman Susan Cruzan.

``A lot of times we know about safety problems because the drugs were marketed in other countries first and used in a wider population,'' Cruzan said.

• More news on About Your Medicines

Related MEDLINEplus Pages:

• About Your Medicines
• Anemia
• Kidney Failure and Dialysis