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The FDA approved Cosentyx for teens 12 and older with severe hidradenitis suppurativa, the first targeted therapy for this condition in pediatric patients.
The FDA has approved Cosentyx (secukinumab) for adolescents aged 12 and older with moderate to severe hidradenitis suppurativa, marking the first targeted therapy approved for this condition in pediatric patients.
The drug, which blocks interleukin-17A, is administered via subcutaneous injection and showed effectiveness in reducing skin symptoms, pain, and improving quality of life in clinical trials.
Approval was based on data from adult trials, pharmacokinetic modeling, and safety information from pediatric use in other conditions.
Treatment uses weight-based dosing and is given every four weeks.
The decision addresses a significant unmet need for teens with this chronic, painful skin disease, which often begins in adolescence and can lead to long-term complications.
La FDA aprobó Cosentyx para adolescentes de 12 años o más con hidradenitis supurativa severa, la primera terapia dirigida para esta afección en pacientes pediátricos.