CHMP recommends Gazyva/Gazyvaro for systemic lupus erythematosus

Roche has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Gazyva/Gazyvaro as an add-on treatment for adults with moderate-to-severe active systemic lupus erythematosus.

The recommendation covers patients with autoantibody-positive SLE whose disease remains active despite standard therapy.

A final decision from the European Commission is expected following the CHMP recommendation.

Gazyva/Gazyvaro, also known as obinutuzumab, is a glycoengineered Type II anti-CD20 monoclonal antibody designed to target B cells involved in autoimmune disease.

The recommendation is supported by results from the Phase III ALLEGORY study.

At Week 52, 76.7% of patients receiving Gazyva/Gazyvaro plus standard therapy achieved at least a four-point improvement on the SLE Responder Index compared with 53.5% of patients receiving placebo plus standard therapy.

The adjusted difference between the groups was 23.1 percentage points, with a 95% confidence interval of 12.5 to 33.6 and a p value below 0.001.

The study also met all key secondary endpoints.

These included British Isles Lupus Assessment Group-based Composite Lupus Assessment response, sustained glucocorticoid reduction, sustained SRI-4 response, SRI-6 response and time to first disease flare.

Remission rates were also higher with obinutuzumab.

Using the Definition of Remission in SLE criteria, 33.8% of patients receiving Gazyva/Gazyvaro achieved remission compared with 13.8% receiving placebo.

The proportion of patients reaching Lupus Low Disease Activity State was 57.6% with Gazyva/Gazyvaro compared with 25.0% with placebo.

The safety profile was consistent with the established profile of obinutuzumab, with no new safety signals identified.

Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, said the recommendation brings the therapy closer to providing another treatment option for people living with SLE who continue to experience flares, progressive organ damage and dependence on long-term steroids.

Systemic lupus erythematosus is a chronic autoimmune disease in which the immune system can attack multiple organs and tissues.

Roche estimates that around three million people worldwide live with the disease, including up to 270,000 people in Europe.

Gazyva/Gazyvaro is already approved for active lupus nephritis in more than 65 countries and for idiopathic nephrotic syndrome in the U.S.

Roche is also developing the medicine across additional immune-mediated diseases, including primary membranous nephropathy.

The company said ALLEGORY is one of four positive Phase III studies of Gazyva/Gazyvaro in immune-mediated conditions, alongside REGENCY in lupus nephritis, INShore in idiopathic nephrotic syndrome and MAJESTY in primary membranous nephropathy.

The U.S. Food and Drug Administration has also accepted Roche’s supplemental Biologics License Application for Gazyva/Gazyvaro in systemic lupus erythematosus.

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Related Topics and Keywords

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