Amgen's Otezla launched for pediatric plaque psoriasis in US

Amgen has introduced Otezla (apremilast) in the United States as a treatment option for pediatric patients aged six to 17 years with moderate to severe plaque psoriasis. This marks the first time an oral medication has been made available for children and adolescents in this category who qualify for phototherapy or systemic therapy. The medication is designed for patients weighing at least 20 kilograms.

The FDA approved Otezla for pediatric use following the results of the Phase III SPROUT clinical trial. This study evaluated the drug's efficacy and safety in children and adolescents who didn't respond well to or couldn't tolerate topical treatments. The trial results were promising, showing that Otezla met its primary endpoint at week 16, achieving a 33.1% response rate in the static Physician’s Global Assessment (sPGA) compared to 10.8% for the placebo. The trial indicated a significant benefit of Otezla over the placebo, with a 95% confidence interval between 12.2% and 32.4%.

The safety profile of Otezla in pediatric patients was similar to that seen in adults, with common side effects including diarrhea, nausea, and headaches. For maintenance, the dosing of Otezla varies based on the patient's weight: those weighing between 20kg and 50kg receive 20mg, while those weighing 50kg or more receive 30mg. Both doses are administered twice daily after an initial titration period.

Otezla works by inhibiting phosphodiesterase 4 (PDE4), leading to increased levels of intracellular cyclic adenosine monophosphate (cAMP). This mechanism is thought to help modulate the production of inflammatory mediators, thus alleviating symptoms associated with plaque psoriasis.

Murdo Gordon, Amgen's Executive Vice-President of Global Commercial Operations, emphasized the significance of this development. He noted that for the first time, children and adolescents suffering from moderate to severe plaque psoriasis now have an oral treatment option. Gordon pointed out that Otezla has been prescribed to over a million adults globally in the past decade, highlighting the potential benefits for younger patients facing this chronic condition with its visible and uncomfortable symptoms.

This announcement follows Amgen's report of a significant financial downturn, with a 45.9% decrease in net income, falling to $746 million in the second quarter of 2024 from $1.3 billion in the same period the previous year.