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Plivensia FDA Approval Status

FDA Approved: No
Brand name: Plivensia
Generic name: sirukumab
Company: Janssen Biotech, Inc.
Treatment for: Rheumatoid Arthritis

Plivensia (sirukumab) is a human anti-interleukin-6 monoclonal antibody in development for the treatment of rheumatoid arthritis.

Development Timeline for Plivensia

DateArticle
Sep 22, 2017Janssen Receives Complete Response Letter From U.S. FDA for Sirukumab Biologics License Application
Aug  2, 2017FDA Advisory Committee Does Not Recommend Approval of Sirukumab for the Treatment of Moderately to Severely Active Rheumatoid Arthritis
Sep 23, 2016Janssen Submits Application Seeking Approval of Sirukumab in United States for Rheumatoid Arthritis

Further information

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