FDA Rejects New Use For J&J Immune Disorder Drug

Healthcare giant Johnson & Johnson plans to meet with U.S. regulators after they refused to approve a new use for the company’s immune disorder drug, Simponi.

The company, based in New Brunswick, N.J., said Friday night that the Food and Drug Administration notified its Janssen Biotech Inc. subsidiary that it would not approve marketing of Simponi for limiting progression of structural damage in patients with moderate to severe rheumatoid arthritis.

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2 Comments
2 comments
  1. Deb aka murphthesurf says:

    I am curious as to why when both Canada and the European equivalent to our FDA have previously approved this for this particular use. Usually these two markets are behind us in releasing things for use…so I want the details as to why the FDA won’t approve it.

  2. Nan Hart says:

    Since I just started on Simponi I called my Rheumatologist but they have not gotten back to me yet….I also want to know why and if this will effect my insurance coverage, etc. Lots of questions to get answers to….Nan

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