FDA slams J&J’s block­buster con­tender sirukum­ab on ‘im­por­tant safe­ty risks’

Just days af­ter Glax­o­SmithK­line dumped its part­ner­ship with J&J on the late-stage rheuma­toid arthri­tis drug sirukum­ab, the FDA helped il­lus­trate why the phar­ma gi­ant was ready to bail at this late date.

In an in­ter­nal re­view out two days ahead of a sched­uled pan­el re­view, reg­u­la­tors spot­light­ed a trou­bling round of safe­ty da­ta for the IL-6 drug, which has pro­vid­ed on­ly mixed ef­fi­ca­cy re­sults so far. Ac­cord­ing to the re­view, there was a clear im­bal­ance in deaths and ma­lig­nan­cies among the pa­tients stud­ied over a 52-week pe­ri­od.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.