Janssen submits application to European Union seeking approval of sirukumab for rheumatoid arthritis

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Sep 12, 2016

Janssen-Cilag International NV (Janssen) has announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of sirukumab for treating adult patients with moderately to severely active rheumatoid arthritis (RA). Approximately 6.2 million Europeans are affected by RA, which is a chronic, systemic inflammatory condition. Sirukumab is a human monoclonal IgG1 kappa antibody targeting IL-6, a naturally occurring protein that is believed to play a key role in autoimmune conditions like RA.

Newman Yeilding, MD, Head of Immunology Development, Janssen Research & Development, LLC, said: “At Janssen, we are committed to continued innovation in the field of rheumatoid arthritis through new therapeutic options, like sirukumab, that address the medical needs of people living with moderately to severely active rheumatoid arthritis. We look forward to collaborating with the European health authorities with the goal of bringing sirukumab to patients living with rheumatoid arthritis who may benefit from this new biologic therapy.”

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