Anvisa approves pediatric medicines for lupus and multiple sclerosis

For children over 5 years of age with active systemic lupus erythematosus (SLE), Benlysta (belimumab) is now indicated as complementary treatment. The medicine is intended for patients who have a high degree of disease activity, and who are already on standard treatment, with corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs or other immunosuppressants.

The measure covers applicator/auto-injector pen alternatives, aiming to reduce the need for trips to infusion centers and the comfort of patients. The intravenous formulation of the drug was already approved for pediatric patients. Another drug that has expanded its use in patients over 12 years old and weighing 40 kg is Ocrevus (ocrelizumab), intended for the treatment of relapsing-remitting multiple sclerosis (RRMS). The product is a recombinant monoclonal antibody, which contributes to reducing the inflammatory activity associated with the disease.

About lupus

Systemic lupus erythematosus is an autoimmune inflammatory disease that can affect multiple organs and tissues, such as the skin, joints, kidneys and brain. In more serious cases, if not treated properly, it can lead to death. The main symptoms include fever, muscle stiffness and swelling, skin lesions that appear or worsen when exposed to the sun, enlarged lymph nodes and hair loss.

According to the Brazilian Society of Rheumatology, the disease affects between 150,000 and 300,000 people in Brazil, mainly women between 20 and 45 years old. The diagnosis is made based on a series of medical tests, such as blood count, kidney biopsy, urine test, among others. Treatment is mainly palliative.

About multiple sclerosis

Multiple sclerosis is a chronic inflammatory and autoimmune disease of the central nervous system. The immune system attacks the myelin that covers and protects nerve fibers, impairing communication between the brain and the rest of the body.

In the relapsing-remitting form, the disease is characterized by episodes of new neurological symptoms or worsening of existing ones, followed by periods of partial or complete recovery. The manifestation of symptoms before the age of 18 is considered a rare and more serious condition of the disease.

Among the most common symptoms are extreme fatigue, numbness, tingling, visual changes (such as blurred or double vision), muscle weakness, imbalance and difficulty controlling the bladder. The causes involve genetic predisposition and environmental factors that act as triggers, such as viral infections, smoking and obesity. The diagnosis is made by a neurologist along with complementary tests.

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