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Actemra Receives FDA Approval for Expanded Indication in Rheumatoid Arthritis

Strategic Insights

— 1 min read

Rheumatoid Arthritis (RA) is a debilitating disease affecting millions in the US, causing joint inflammation and progressive joint damage. Actemra, a humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody, has been extensively studied for its safety and efficacy in treating RA. On December 20, 2011, Chugai Pharmaceutical Co Ltd. and F. Hoffmann-La Roche Ltd announced that Genentech Inc had submitted a supplemental biologics license application to the FDA seeking approval of Actemra for an expanded indication. This expansion aims to eliminate the condition of inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies from the current indication.

Key Takeaways:

  • Actemra is a humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody developed by Chugai in collaboration with Osaka University.
  • Actemra works by inhibiting IL-6 biological activity through competitively blocking the binding of IL-6 to its receptor.
  • The FDA has received a supplemental biologics license application for Actemra to treat adult patients with RA, with inadequate response to one or more TNF antagonist therapies.
  • The sBLA is based on comprehensive safety data from extensive clinical trial programs, extension studies, and data collected in clinical settings after initial approvals in the world.
  • The safety profile of Actemra is consistent with previous findings, even after long-term usage.
  • Actemra was initially approved in Japan in June 2005 for Castleman's disease and subsequently for additional indications, including RA, polyarticular-course juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
  • Actemra has been approved in over 90 countries, including the US, EU, India, Brazil, Switzerland, and Australia.
  • In the US, Actemra is approved for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients two years of age and older.

Statistics:

  • Actemra has been approved in over 90 countries.
  • The safety profile of Actemra is consistent with previous findings, even after long-term usage.
  • Actemra was first approved in Japan in June 2005.
  • The US FDA received a supplemental biologics license application (sBLA) on December 20, 2011.
  • Actemra is approved for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients two years of age and older.

Sources:

  • [1] Chugai Pharmaceutical Co Ltd, F. Hoffmann-La Roche Ltd, and Genentech Inc. (December 20, 2011). "Genentech Announces Submission of Supplemental Biologics License Application to U.S. FDA for Actemra (Tocilizumab) for Treatment of Rheumatoid Arthritis."

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