Published in the Official Gazette, the decision expands therapeutic options for pediatric patients with both autoimmune diseases and includes new indications for the drugs Benlysta (belimumab) and Ocrevus (ocrelizumab).

  Regarding active systemic lupus erythematosus, Anvisa authorized the use of Benlysta as an add-on therapy for children aged five and older who exhibit high disease activity and are receiving conventional treatment.

  Likewise, the regulatory agency approved the expanded use of Ocrevus for adolescents aged 12 and older—weighing at least 40 kilograms—diagnosed with relapsing-remitting multiple sclerosis.

  As a recombinant monoclonal antibody, the drug works by reducing the inflammatory activity associated with the disease, which is characterized by episodes of new or worsening neurological symptoms followed by periods of partial or total recovery.

  Data from the Brazilian Society of Rheumatology indicate that between 150,000 and 300,000 people in Brazil suffer from this disease, primarily women between the ages of 20 and 45.

  Meanwhile, multiple sclerosis is a chronic inflammatory condition in which the immune system attacks myelin—the substance protecting central nervous system fibers—thereby affecting communication between the brain and the rest of the body.

  Although the onset of the condition before age 18 is rare, specialists warn that it is often associated with more aggressive forms of the disease.

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