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FDA Committee Backs Bristol Drug

The advisers unanimously recommended approval of Orencia.

Bristol-Myers Squibb's

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experimental rheumatoid arthritis drug was unanimously recommended for approval by a Food and Drug Administration advisory committee.

Trial data suggest that Orencia, known generically as abatacept, improves the physical function of rheumatoid arthritis patients after a year of treatment when antirheumatic drugs or TNF blocker therapies fail. TNF (tumor necrosis factor) blockers are a class of anti-inflammatory drugs.

An FDA advisory committee met Tuesday to determine whether another year of efficacy data would be required for approval of the drug. The committee voted 7-0 to recommend approval based on data that are already available. The FDA isn't necessarily bound by its committee's votes.

According to a recent FDA briefing document, in order for Bristol to officially claim that the drug improves physical function, the benefits must last two years.

Bristol says the FDA will require up to 90 more days to complete its review of abatacept because of the complexity of the chemistry and manufacturing controls section of the drug application. The biologics license application for the drug was submitted to regulators in March, and the original FDA action date was Oct. 1.

Shares of Bristol fell 10 cents to $24.85 in after-hours trading.

The company expects to file a supplemental application for a second manufacturing facility as soon as possible after the drug application is approved -- providing of course that it is -- in order to meet anticipated demand.

Bristol is seeking an indication that says the drug reduces signs and symptoms of rheumatoid arthritis, produces a major clinical response, inhibits the progression of structural damage and improves the physical function of patients with moderately to severely active rheumatoid arthritis who haven't responded well to standard therapies.

The New York-based company initially also wanted to market the drug as part of a combination treatment with other antirheumatic drugs, but later backed off of that aim. The advisory committee agreed that Orencia shouldn't be used jointly with biologic therapies.

One concern is the increased risk of infection when abatacept is used with biologic treatments such as the anti-TNF agents Humira from

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In a trial to determine the safety of combining Orencia with other rheumatoid arthritis therapies, 5.8% of patients who took both Orencia and a biologic drug had severe infections compared with 1.6% of subjects receiving a placebo and a biologic option.