First Severe Plaque Psoriasis Oral Therapy for Ages 6-17 Now Available in US

A significant development has emerged in the treatment of pediatric plaque psoriasis as Otezla has become the first oral medication approved by the FDA for children and adolescents in this category. This groundbreaking approval, announced earlier this year, provides a new therapeutic option for young patients who are eligible for phototherapy or systemic therapy and weigh at least 20 kg (44 lbs). Until now, treatment alternatives for this patient group were confined to injections or infusions.

Murdo Gordon, executive vice president of global commercial operations at Amgen, underscored the importance of this milestone by mentioning that Otezla has been prescribed to over one million adults globally in the past ten years. "For the first time, children and adolescents with moderate to severe plaque psoriasis and their caregivers have an oral option to treat this chronic disease," he stated.

Plaque psoriasis is a persistent immune-mediated disorder where patients suffer from highly visible, itchy, and often painful skin lesions. Leah M. Howard, JD, President and CEO of the National Psoriasis Foundation, highlighted the significance of this new treatment option: “The addition of an oral treatment option with a well-established safety profile is great news for children with this disease and their families.”

The FDA’s decision was grounded in the results of the Sprout study, a phase 3, multicenter, randomized, placebo-controlled, double-blind trial that examined Otezla's efficacy and safety in pediatric patients. The study accomplished its primary endpoint, demonstrating a notable improvement in the static Physician's Global Assessment (sPGA) response at week 16. Specifically, 33.1% of patients treated with Otezla achieved a clear or almost clear score, in contrast to just 10.8% of those on placebo. The safety profile for pediatric patients matched that seen in adults.

Common side effects of Otezla include diarrhea, nausea, upper respiratory tract infections, and headaches. The maintenance dose is dependent on the patient’s weight, with 20 mg administered twice daily for those weighing between 20 kg and 50 kg, and 30 mg twice daily for those weighing 50 kg or more.

Amgen has reaffirmed its dedication to ensuring that patients have affordable access to Otezla. As of 2024, Amgen remains a leader in biotechnology, focusing on developing innovative therapies aimed at addressing some of the world’s most challenging diseases.

This latest approval further strengthens Amgen’s position in the psoriasis treatment field, providing a new solution for younger patients dealing with this chronic condition.

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