RegulatoryCompany release

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

F. Hoffmann-La Roche Ltd · Fri 13 Nov 2026

The EMA committee has backed obinutuzumab for adults with moderate-to-severe, active systemic lupus erythematosus despite standard therapy, with a European Commission decision expected shortly.

Roche announced on 13 November 2026 that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Gazyvaro (obinutuzumab; Gazyva in the US) as an add-on treatment for systemic lupus erythematosus (SLE).

The recommendation covers adults with moderate-to-severe, active, autoantibody-positive SLE whose disease persists despite standard therapy. The company says a European Commission decision is expected shortly.

Roche also states that the US Food and Drug Administration has accepted its supplemental Biologics License Application for the SLE indication, so the product is under review on both sides of the Atlantic.

The medicine is already approved for lupus nephritis in more than 65 countries and for idiopathic nephrotic syndrome in the US, according to the company.

For context, a CHMP opinion is not itself a marketing authorisation. The European Commission normally issues a legally binding decision after the committee's positive opinion.

What it means for your team

  • Regulatory teams should watch for the European Commission decision, which turns the CHMP opinion into an authorisation for the SLE indication in the EU.
  • Market-access teams in lupus should note a potential new add-on option for autoantibody-positive patients inadequately controlled on standard therapy, with a parallel FDA review under way.
  • Pharmacovigilance teams may need to prepare for an extended obinutuzumab patient population, given existing use in lupus nephritis and nephrotic syndrome.

Company's press release: F. Hoffmann-La Roche Ltd ↗

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

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