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Roche’s Gazyva wins CHMP recommendation for EU approval in lupus

By Public Technologies
  • Roche received a positive EU regulatory recommendation for Gazyva/Gazyvaro in systemic lupus erythematosus on November 13, 2026.
  • The recommendation covers add-on treatment for adults with moderate-to-severe, active, autoantibody-positive disease despite standard therapy.
  • A final European Commission decision is expected soon; the FDA accepted the supplemental application earlier this year.
  • Previously reported phase III ALLEGORY results showed improved disease control, higher remission rates and reduced steroid use compared with placebo.
  • The trial identified no new safety signals, supporting potential expansion beyond the drug’s existing immune-mediated disease indications.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Roche Holding AG published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202611130630OMX_____CNEWS_EN_GNW1001303478_en) on November 13, 2026, and is solely responsible for the information contained therein.

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