Amgen has announced the availability of Otezla (apremilast) in the US for paediatric patients with moderate to severe plaque psoriasis, [a skin lesion condition].
It is the first and only pill for children and adolescents aged six to 17 years who are candidates for phototherapy or systemic therapy.
The treatment is available for those weighing a minimum of 20kg.
The US Food and Drug Administration (FDA) earlier approved Otezla based on the data from the Phase III SPROUT clinical trial.
This trial assessed the efficacy and safety of the medication in patients inadequately controlled by or intolerant to topical therapy.
Otezla met the primary endpoint at week 16, with a 33.1% static Physician’s Global Assessment (sPGA) response compared to 10.8% for placebo.
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The SPROUT trial’s results also showed a clear benefit of Otezla over placebo, with a 95% confidence interval of 12.2% and 32.4%.
Otezla’s safety profile observed in paediatric patients was consistent with that of adults, with diarrhoea, nausea and headaches being the most common side effects.
For the maintenance dosage, patients will receive either 20 or 30mg doses of Otezla twice daily after the initial titration period.
The dose depends on the patient’s weight, with those weighing between 20kg and 50kg receiving 20mg, and those 50kg and above receiving 30mg.
Otezla functions as an inhibitor of phosphodiesterase 4 (PDE4), which increases levels of intracellular cyclic adenosine monophosphate (cAMP). This is believed to indirectly modulate the production of inflammatory mediators.
Amgen global commercial operations executive vice-president Murdo Gordon stated: “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, with its highly visible, uncomfortable symptoms.
“In the last decade, Otezla has been prescribed to over one million adults worldwide, and the announcement represents the potential for Otezla to offer relief to many younger patients.”
The latest development comes after Amgen reported a 45.9% decrease in net income to $746m in the second quarter (Q2) of 2024 compared to $1.3bn in the same period of the previous year.
