Novartis has announced that Cosentyx (secukinumab) received approval from the European Commission for the treatment of moderate-to-severe psoriasis in pediatrics (children from 6 years to less than 18 years).
The recommended posology is 75mg for children weighing up to 50 kg and 150 kg for children who are more than 50 kg.
The approval was based on the two-Phase III global studies, including the patients with age between 6 to <18 years. Novartis has announced that low-dose (75-150 mg) and high-dose (75-300 mg) of Cosentyx was efficacious in improving the skin conditions and quality of life. Among the patients who were administered with low-dose Cosentyx, 93% of patients achieved the Psoriasis Area Severity Index (PASI) 75 at week 12, and 69% of patients achieved PASI 90 at week 12. PASI100 was achieved in 59.5% of patients by week 12 and 67% by week 24.
European Commission is the first to approve Cosentyx for pediatric patients suffering from psoriasis. The company is seeking approval in the US, Australia, Canada, and Japan.
Cosentyx has been approved previously for psoriasis, psoriatic arthritis, ankylosing spondylitis. Recently the product has received approval for non-radiographic axial spondylitis.