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Plivensia 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 Status and FDA Approval Process 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
Nov 16, 2016GSK Announces New Data from Phase III Studies of Sirukumab in Adult Patients with Moderately to Severely Active Rheumatoid Arthritis
Sep 23, 2016Janssen Submits Application Seeking Approval of Sirukumab in United States for Rheumatoid Arthritis
Jun  8, 2016GSK announces phase III study of sirukumab meets both co-primary endpoints in patients with rheumatoid arthritis
Dec 16, 2015GSK receives positive top-line results from sirukumab phase III programme supporting regulatory filings for rheumatoid arthritis in 2016
Nov 25, 2015GSK Announces Start of Phase III Study of Sirukumab in Giant Cell Arteritis
May 25, 2011Interleukin-6 Inhibitor Sirukumab (CNTO 136) Phase 2 Data Show Promise in the Treatment of Active Rheumatoid Arthritis

Further information

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