Johnson & Johnson has been left “disappointed” after the FDA rejected its rheumatoid arthritis drug Plivensia (sirukumab). Efficacy is not the issue – but in a complete response letter to Janssen Biotech, the US regulator said that it needs additional clinical data to further evaluate its safety in the treatment of moderately to severely active RA.

This blow was heavily signposted: in August an FDA advisory committee voted 12 to 1 against recommending sirukumab, citing question marks over the risk to patients. But it is still not what Janssen wanted to hear. Newman Yeilding, Head of Immunology Development, Janssen R&D, said: “We are disappointed by this development as we feel the data accumulated to date support the efficacy and safety of sirukumab.”

He went on: “We are reviewing the details of the complete response letter and plan to have a follow-up discussion with the agency to gain a full understanding of FDA requirements for US approval.”

The drug targets the IL-6 cytokine in the treatment of RA. Efficacy and safety data come from a global Phase III clinical development programme, involving more than 3,000 patients living with RA, including those who have taken previous disease modifying anti-rheumatic drugs (DMARDs) and biologic treatments. There were a higher number of fatalities in the treatment group versus placebo, due in the main to cardiovascular problems, malignancies and infection.

Yeilding, who has already strongly questioned the Arthritis Advisory Committee’s interpretation of the risk/benefit profile, insists that the fully human monoclonal IgG1 kappa antibody “represents an important therapeutic option for patients living with RA, especially for those individuals who cycle through multiple treatments and continue to struggle to find an effective option for a potentially disabling disease”.

Currently under review by health authorities in Europe and Japan, sirukumab is not yet approved as a treatment for any indication.

Janssen holds exclusive rights to commercialise it in Europe, the Middle East, Africa and Asia Pacific, and will regain global rights in November after GSK terminated an agreement which allowed it commercialisation rights in North, Central and South America.