Genentech Submits Supplemental Biologics License Application for ACTEMRA for Prevention of Structural Joint Damage in Rheumatoid Arthritis Patients

Strategic Insights -

Genentech has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for ACTEMRA (tocilizumab) for the prevention of structural joint damage and improvement in physical function in adults with moderately to severely active rheumatoid arthritis. ACTEMRA was approved by the FDA in 2010 as the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody to treat RA in adult patients after an inadequate response to at least one other medicine. The application is based on positive results from the Phase III LITHE trial, which showed that patients receiving ACTEMRA in combination with methotrexate had significantly less damage to their joints compared to patients who received methotrexate alone. The LITHE study also demonstrated significant improvement in physical function in patients receiving ACTEMRA plus methotrexate.

Key Takeaways:

  • Genentech submitted a supplemental Biologics License Application to the FDA for ACTEMRA (tocilizumab) for the prevention of structural joint damage in rheumatoid arthritis patients.
  • ACTEMRA was approved by the FDA in 2010 for the treatment of adult patients with moderately to severely active RA after an inadequate response to at least one other medicine.
  • The Phase III LITHE trial showed that patients receiving ACTEMRA in combination with methotrexate had significantly less damage to their joints compared to patients who received methotrexate alone.
  • At 104 weeks, total Genant-modified Sharp Score change from baseline for the ACTEMRA 8mg + MTX, 4mg +MTX, and MTX alone groups were 0.37, 0.58, and 1.96, respectively.
  • The Health Assessment Questionnaire Disability Index (HAQ-DI) AUC change from baseline, adjusted mean scores were -144.1, -128.4, and -58.1 for the ACTEMRA 8mg + MTX, 4mg +MTX, and MTX alone groups, respectively, at Week 52.
  • Results from the 24-month analysis showed that patients receiving ACTEMRA plus methotrexate had significant improvement in physical function compared to patients receiving methotrexate alone.
  • Serious side effects associated with ACTEMRA include serious infections, gastrointestinal perforations, and hypersensitivity reactions, including anaphylaxis.
  • ACTEMRA has been approved in the European Union, Japan, and several other countries, including India, Brazil, Switzerland, and Australia.

Statistics:

  • 1196 patients with moderate to severe RA participated in the LITHE study.
  • 1.3 million adults in the United States are affected by rheumatoid arthritis.
  • Less than 50 percent of patients with RA can continue to work or function normally on a daily basis after 10 years.
  • ACTEMRA has been studied in over 4,000 patients with RA in 41 countries, including the United States.
  • 81% less damage to joints was seen in patients treated with ACTEMRA 8mg/kg plus MTX compared to those treated with MTX alone at Week 104 based on Total-Sharp Genant Score.

Sources:

  • Genentech press release
  • ClinicalTrials.gov
  • http://www.actemra.com
  • http://www.gene.com
  • Arthritis Foundation

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