Death risk warning ahead of FDA meeting on RA drug

Safety will be a major topic when the merits or otherwise of sirukumab injection, a drug from US healthcare giant Johnson & Johnson’s (NYSE: JNJ) Janssen Biotech unit, is discussed by the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) on Wednesday.

Janssen is seeking approval to use the drug, which has the proposed brand name Plivensia, to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs.

As ever, the FDA has prepared a report reviewing the application and alerting the committee to some of the points to consider during the meeting. Top of the list for points to discuss is the issue of safety, with Phase III program results showing an imbalance in death between sirukumab and placebo.