Amgen gets green light from FDA for more Enbrel

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[size=18]Amgen gets green light from FDA for more Enbrel[/size]


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By Luke Timmerman
Seattle Times business reporter

The Food and Drug Administration has cleared Amgen's new factory to start shipping Enbrel, a move that will alleviate the drug's shortage and ease chronic pain for tens of thousands of patients.

The approval ends a three-year saga in which Seattle-based Immunex and its partner Wyeth raced to retrofit the factory to catch up with soaring demand for the rheumatoid-arthritis drug.

Immunex started work on the $450 million project, but the job was finished by Amgen, which took over Immunex last summer.

The factory will roughly double Enbrel production, enabling the Thousand Oaks, Calif.-based biotech leader to supply about 160,000 patients instead of 80,000. The company expects to be able to wipe out a 40,000-patient waiting list for the drug.

To Amgen's business, the approval means Enbrel sales are expected to shoot up from a plateau of about $800 million this year to between $1.2 billion and $1.4 billion next year.

For patients, the factory approval will give them access to a drug that dramatically reduces pain, swelling and erosion of joints found with rheumatoid arthritis and psoriatic arthritis.