August 2nd AAC Meeting: FDA Concerns Over Sirukumab Deaths Save

On August 2, the US Food and Drug Administration (FDA) will convene a hearing of the Arthritis Advisory Committee (AAC) to review the safety of the novel IL-6 inhibitor, sirukumab, being developed by Janssen (Johnson & Johnson). Specifically, FDA reviewers have concerns over the number of deaths on sirukumab compared to those receiving placebo.

The most common causes of death noted in the sirukumab trials were cardiovascular, infectious and neoplastic-related deaths.

The meeting agenda calls for discussion of drug safety, the imbalance of deaths, the efficacy of the drug, appropriate dosing and whether the drug should be approved for use in patients with moderately to severely active rheumatoid arthritis that has had an inadequate response to DMARD therapy.

If approved sirukumab would be known as Plivensia.  While the drug was codeveloped with GlaxoSmithKline (GSK), GSK has recently decided to end its involvement and return all rights to J&J. 

Other currently marketed IL-6 inhibitors,  Actemra and Kevzara (sarilumab), do not have major warnings with regard to cardiovascular death or other causes of death.

The addition of a third IL-6 inhibitor would grow the market to over $3 billion in sales by 2020, with tocilizumab expected to top $2 billion in sales by 2020.