Anvisa (the Brazilian health regulatory agency) has approved the registration of medications to treat psoriasis and asthma.

The National Health Surveillance Agency (Anvisa) today (11) published the registration of two drugs: one for the treatment of chronic inflammatory and autoimmune diseases, and another for severe asthma and chronic rhinosinusitis with nasal polyps. The first drug approved is Yesintek (ustekinumab), presented as a ready-to-use injectable solution for subcutaneous administration and intravenous infusion. The drug is indicated for the treatment of psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. According to Anvisa, the product was evaluated through a comparability development pathway, having been compared to the Stelara drug. "Yesintek is a biosimilar, meaning it demonstrates similarity in terms of quality, safety, and efficacy compared to a previously registered biological reference product," said the regulatory agency. The agency also stated that the approved drug is a new therapeutic alternative for adult patients and children over 6 years old with moderate to severe plaque psoriasis. "The treatment is specifically targeted for cases where conventional therapies—such as the use of cyclosporine, methotrexate, or phototherapy sessions (PUVA)—have not produced satisfactory results, have been contraindicated, or have caused intolerance." According to the regulatory agency, in the case of adult patients with active psoriatic arthritis, the drug can be used alone or in combination with methotrexate, when the response to treatment with disease-modifying antirheumatic drugs (DMARDs) has been inadequate. Yesintek is also indicated for children over 6 years old with active disease. In the case of Crohn's disease, the drug is indicated for adult patients with moderate to severe active disease who have had an inadequate response or loss of response to other treatments, as well as individuals who are intolerant to conventional therapy or anti-TNF-alpha (immunobiological drugs that block a specific protein, reducing chronic inflammation), or who have medical contraindications for these therapies. Asthma and Chronic Rhinosinusitis Also on Monday, Anvisa published the registration of a new drug for the treatment of asthma and severe chronic rhinosinusitis with nasal polyps, Densurko® (depemokumab). The medication is presented as a 100 mg/mL injectable solution, in pre-filled syringes or applicators, ready for use, and is indicated as an adjunct treatment for asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation (allergic), characterized by an excess of eosinophils (white blood cells involved in airway inflammation) in the blood. According to the agency, clinical studies have demonstrated a significant reduction in the rate of clinically significant exacerbations compared to placebo, both in combination with standard treatment. In the case of chronic rhinosinusitis with nasal polyps, the drug is indicated only for adult patients in whom conventional therapy (with systemic corticosteroids) and/or surgery do not provide adequate control of the condition. In both cases, the indicated treatment is one dose every six months.