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Arthritis drug moves towards approval
Good news for Bristol as FDA advisory panel votes in favor of abatacept, a rheumatoid arthritis drug
September 6, 2005: 4:42 PM EDT
By Aaron Smith, CNN/Money staff writer

NEW YORK (CNN/Money) - A panel of experts advising the FDA voted unanimously in favor of abatacept, a Bristol-Myers Squibb treatment for rheumatoid arthritis, in a move that often precedes approval of a drug by the regulatory agency.

Abatacept, also known by its trade name Orencia, is designed to reduce swelling and pain and to treat structural damage in joints gnarled by rheumatoid arthritis.

All seven panelists voted "yes" when asked if the drug's benefits "outweigh the known and potential risks," a spokesman for the Food and Drug Administration said Tuesday. The agency still has to decide whether to approve the Bristol-Myers (up $0.49 to $24.95, Research) drug, but it usually follows the guidance of its advisors.

"We look forward to working with the FDA on bringing the product to patients in need," Elliott Sigal, president and chief scientific officer for Bristol-Myers, said in a statement.

The drug had been granted fast-track review process, which usually takes six months. Abatacept was submitted in March.

Deutsche Bank analyst Barbara Ryan said the vote was "completely in line with our expectation, with a unanimous endorsement from the panel." Ryan said she expected the drug to receive full FDA approval in the next few weeks.

Abatacept is the first of two Bristol-Myers drugs that are being voted on by Food and Drug Administration experts this week.

An FDA panel of diabetes experts is due to vote on Bristol-Myers' muraglitazar on Friday. The drug, also known by its trade name Pargluva, is a dual-use drug for diabetes that is being co-developed by Bristol-Myers and Merck (up $0.16 to $28.99, Research).

Test results have shown that the drug can lower blood sugar in type 2 diabetics and reduce the risk of heart disease. Type 2 is the most common type of diabetes and heart disease affects millions of Americans.

The outcome of the FDA panel votes are important to Bristol-Myers, which is losing the patent on Pravachol, a cholesterol-lowering drug and one of its most profitable, next year. Sales of the drug totaled $2.6 billion last year.

Even if abatacept and muraglitazar are both approved and enter the market next year, they'll have a difficult time filling the revenue void left by Pravachol.

Merrill Lynch analyst David Risinger has projected that abatacept sales could reach $1.1 billion in 2009, pending FDA approval. But the projection from Bernstein analysts is less than half that amount: $450 million for abatacept by 2009.

Bernstein analysts are bullish on Muraglitazar, projecting more than $2.2 billion in sales for 2009. However, these sales would be divided by Bristol-Myers and its partner Merck.

For more on abatacept and muraglitazar, click here.  Top of page

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