FDA OKs Bristol-Myers Drug for Rheumatoid Arthritis
LOS ANGELES (Reuters) Dec 27 - Bristol-Myers Squibb Co. said on Friday that it has won U.S. approval to sell a new type of drug for treating rheumatoid arthritis.
The drug, Orencia (abatacept), is the first approved T-cell co-stimulation modulator. It is administered by monthly intravenous infusion.
Orencia was approved for treating moderate to severe cases of rheumatoid arthritis that do not respond to one or more other therapies.
Three Bristol-Myers studies showed more patients had a 20% improvement in rheumatoid arthritis symptoms when treated with Orencia rather than a placebo. In one study, 61% of Orencia patients, compared with 35% of placebo patients, saw that level of benefit during 6 months of therapy.
Like TNF-alpha inhibitors, Orencia was associated with a risk of infections. Serious infections occurred in 3% of patients treated with Orencia, compared with 1.9% who received a placebo.
The drug, Orencia (abatacept), is the first approved T-cell co-stimulation modulator. It is administered by monthly intravenous infusion.
Orencia was approved for treating moderate to severe cases of rheumatoid arthritis that do not respond to one or more other therapies.
Three Bristol-Myers studies showed more patients had a 20% improvement in rheumatoid arthritis symptoms when treated with Orencia rather than a placebo. In one study, 61% of Orencia patients, compared with 35% of placebo patients, saw that level of benefit during 6 months of therapy.
Like TNF-alpha inhibitors, Orencia was associated with a risk of infections. Serious infections occurred in 3% of patients treated with Orencia, compared with 1.9% who received a placebo.
posted by Ricardo Pocurull at 6:42 AM
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