RegulatoryCompany release

CHMP backs Roche's Gazyvaro as add-on therapy for autoantibody-positive lupus

Roche · Fri 13 Nov 2026

The EMA committee has recommended obinutuzumab for adults with moderate-to-severe, active SLE despite standard therapy, based on phase III ALLEGORY data; a European Commission decision is expected soon.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Roche's Gazyva/Gazyvaro (obinutuzumab) in systemic lupus erythematosus (SLE), Roche announced on 13 November 2026.

The recommendation covers use as an add-on treatment in adults with moderate-to-severe, active, autoantibody-positive SLE whose disease remains active despite standard therapy.

The opinion rests on the phase III ALLEGORY trial. At week 52, 76.7% of patients receiving obinutuzumab achieved an SRI-4 response, compared with 53.5% of those on placebo. Roche reports no new safety signals in the study.

A European Commission decision is expected soon. As general context, the Commission usually follows a CHMP opinion when granting an EU marketing authorisation or extension of indication. Roche also said the US Food and Drug Administration has accepted a supplemental Biologics License Application for the same indication.

What it means for your team

  • Regulatory teams should watch for the European Commission decision, which would formalise the new lupus indication for Gazyvaro in the EU.
  • Market-access teams in lupus should note a potential new add-on option for autoantibody-positive SLE, with reimbursement planning dependent on the final label.
  • Pharmacovigilance teams can note that Roche reports no new safety signals in ALLEGORY; post-authorisation monitoring will follow the final approved terms.
  • The accepted FDA supplemental BLA means parallel US and EU decisions on the same indication are in progress.

Company's press release: Roche ↗

Article written by VigiEye from the official source (Roche). Claims are the company's own. AI-assisted; check the source before acting.

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