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Autoimmune-Summaries: Daily Autoimmune Updates at a Glance

  • decodeMR Team
  • 8 hours ago
  • 1 min read

21/04/2026













FDA accepted application for Roche’s Gazyva for the treatment of SLE (Ref)


Roche announced that the US FDA had accepted a supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab; anti-CD20) for the treatment of patients with systemic lupus erythematosus (SLE).


  • The filing acceptance was based on positive results from the phase 3 ALLEGORY/ NCT04963296 study, which demonstrated a statistically significant and clinically meaningful benefit in the primary endpoint of SLE Responder Index 4 (SRI-4) at 52 weeks.


  • The FDA was expected to make a decision on approval by December 2026.



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