FDA ex­perts turn thumbs down on J&J’s trou­bled rheuma­toid arthri­tis drug sirukum­ab

Faced with a big red flag reg­u­la­tors raised on safe­ty, a pan­el of out­side ex­perts turned thumbs down on ap­prov­ing J&J’s sirukum­ab for rheuma­toid arthri­tis, con­clud­ing that there wasn’t a clear enough un­der­stand­ing of the drug’s safe­ty pro­file to jus­ti­fy the risk of putting it on the mar­ket.

The vote was 12 to 1 against the drug, say­ing that the safe­ty pro­file did not jus­ti­fy an OK. That was the key is­sue, and they fol­lowed up by the same num­bers in a for­mal vote against an ap­proval.

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