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The U.S. Food and Drug Administration has declined to approve Johnson & Johnson's rheumatoid arthritis drug sirukumab, saying additional clinical data is needed to further evaluate its safety, the company said on Friday. The FDA's decision is in keeping with an advisory panel's recommendation in August that the FDA reject the drug. "We are disappointed by this development as we feel the data accumulated to date support the efficacy and safety of sirukumab," He added that the company is seeking to "gain a full understanding of FDA requirements for U.S. approval" and plans to have a follow-up discussion with the agency.
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