FDA declines to approve J&J arthritis drug sirukumab

From Reuters - September 22, 2017

(Reuters) - The U.S. Food and Drug Administration has declined to approve Johnson & Johnsons rheumatoid arthritis drug sirukumab, saying additional clinical data is needed to further evaluate its safety, the company said on Friday.

The FDAs decision is in keeping with an advisory panels recommendation in August that the FDA reject the drug. Panelists were concerned about an imbalance in the number of deaths in patients taking sirukumab compared with those taking a placebo.

The most common causes of death were major heart problems, infection and malignancies.

We are disappointed by this development as we feel the data accumulated to date support the efficacy and safety of sirukumab,said Dr. Newman Yeilding, head of immunology at J&Js Janssen subsidiary. He added that the company is seeking to gain a full understanding of FDA requirements for U.S. approval and plans to have a follow-up discussion with the agency.

Sirukumab blocks a cytokine in the body known as interleukin 6 that can contribute to the inflammation associated with rheumatoid arthritis, an autoimmune disorder that affects more than 23 million people worldwide.


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