Amgen Gets OK on Enbrel for Psoriasis

Amgen Inc. won U.S. approval Friday to market its rheumatoid arthritis drug Enbrel as a treatment for the skin disorder psoriasis.

A Food and Drug Administration spokeswoman said Enbrel had been approved for chronic moderate to severe psoriasis, an inflammatory condition that causes red, scaly patches of skin and afflicts more than 7 million people in the United States.

The injected drug has been sold for several years, in partnership with Wyeth, as a treatment for the painful joint disorder rheumatoid arthritis and psoriatic arthritis, where inflammation is accompanied by psoriasis.

Amgen spokeswoman Andrea Rothschild said more than half of the 1.5 million Americans with serious psoriasis were untreated. “There’s just a huge untapped opportunity, and now that we’ve received the approval we can really go after it,” she said.

The FDA did not require the drug’s label to include concerns about patient monitoring, disease rebound or flare-ups, she added.

First-quarter Enbrel sales were $397 million. Analysts have said approval for psoriasis could add $700 million to $800 million per year to U.S. sales.

Thousand Oaks-based Amgen’s shares rose 1.6% to $57.30 in after-hours trading from their close at $56.41 on Nasdaq.

“It’s an important but expected event for Amgen,” said James Reddoch, an analyst for Friedman, Billings & Ramsey. “We expect this approval to be a catalyst for Enbrel sales in the second half of the year.”

Reddoch said doctors had already given Enbrel a head start by prescribing the drug as an off-label use for psoriasis before Friday’s approval.

“This allows the company to really put a full-force marketing effort behind it,” he said.