FDA Panel Backs New Use for Amgen Drug

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From Bloomberg News

Amgen Inc., the world’s biggest biotechnology company, moved closer to U.S. approval of expanded marketing claims for its Enbrel rheumatoid arthritis drug by winning the backing of a government advisory committee.

The panel voted 6 to 0 to tell the Food and Drug Administration that the benefits of Enbrel in treating a painful spine disorder called ankylosing spondylitis outweigh its risks. The FDA will consider the advice as it decides on Amgen’s application.

Enbrel “has shown an impressive response” in treatment of ankylosing spondylitis, said Howard Williams, a University of Utah arthritis specialist and chairman of the panel.


Many people with the disease already use Enbrel if they can afford the cost, about $13,000 a year, Williams said. Approval for use in ankylosing spondylitis would make it easier for patients to get insurance coverage, analysts said.

Shares of Thousand Oaks-based Amgen rose 93 cents to $65.05 on Nasdaq.

Ankylosing spondylitis “is not going to add another $1 billion to Enbrel sales, but it will be positive news” if Amgen gets the new marketing claim, said Sena Lund, a Cathay Financial analyst who rates Amgen “outperform.” Enbrel sales may reach $1.35 billion this year, Lund said.

Amgen said it expected an FDA decision by year’s end.

Enbrel is the biggest product Amgen acquired last year with its purchase of Immunex Corp.