OTEZLA® (APREMILAST) APPROVED IN U.S. FOR MODERATE TO SEVERE PEDIATRIC PLAQUE PSORIASIS

Amgen has announced the availability of Otezla® (apremilast) in the U.S. for pediatric use. The FDA approved Otezla earlier this year for treating moderate to severe plaque psoriasis in children and adolescents aged 6 and older, who weigh at least 44 pounds and are candidates for phototherapy or systemic therapy. This marks the first FDA-approved oral medication for moderate to severe plaque psoriasis in this age group.

Murdo Gordon, Executive Vice President of Global Commercial Operations at Amgen, highlighted the significance of having an oral treatment option for younger patients suffering from this chronic condition. He noted that Otezla has been prescribed to over one million adults worldwide and expressed optimism about its potential to alleviate symptoms in children and adolescents.

Leah M. Howard, President and CEO of the National Psoriasis Foundation, also emphasized the importance of this development. She pointed out that, until now, systemic treatment options for youth have been limited to injections or infusions. The introduction of an oral treatment with a well-established safety profile is a significant advancement for children and their families.

The FDA's approval was based on the results from a Phase 3 study named SPROUT. This multicenter, randomized, placebo-controlled, double-blind study evaluated the efficacy and safety of Otezla in pediatric patients aged 6 to 17 with moderate to severe plaque psoriasis inadequately controlled by or intolerant to topical therapy. The study met its primary endpoint at week 16, with a 33.1% response rate for Otezla compared to 10.8% for placebo. The adverse events observed were consistent with the known safety profile of Otezla in adults.

Common side effects of Otezla include diarrhea, nausea, upper respiratory tract infection, tension headache, and headache. After an initial titration period, the maintenance dosage is determined by weight, with 20 mg doses twice daily for those weighing between 44 and 110 pounds, and 30 mg doses twice daily for those weighing more than 110 pounds.

Amgen is committed to ensuring that patients with plaque psoriasis have access to affordable treatments, including Otezla. The company has a long-standing history of innovation in the biotechnology field, focusing on developing medicines to combat some of the world's most challenging diseases.

Plaque psoriasis is a chronic condition characterized by the rapid buildup of skin cells, leading to red or discolored, scaly, and itchy patches on the skin. Approximately 125 million people globally suffer from psoriasis, with about 80% of them having plaque psoriasis. Among pediatric patients, one in five experiences moderate to severe symptoms, and about one-third of psoriasis cases manifest before the age of 18.

Otezla® (apremilast) is an oral medication that inhibits phosphodiesterase 4 (PDE4), leading to increased levels of cyclic adenosine monophosphate (cAMP) within cells. This is believed to modulate the production of inflammatory mediators, although the exact mechanisms by which Otezla exerts its therapeutic effects are not entirely understood. Since its initial FDA approval in 2014, Otezla has been used by over one million patients worldwide.

Otezla is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy, pediatric patients aged 6 years and older with moderate to severe plaque psoriasis, adult patients with active psoriatic arthritis, and adult patients with oral ulcers associated with Behçet's Disease. However, it is contraindicated in patients with known hypersensitivity to apremilast or any component of the formulation.

Warnings include the need to monitor for severe diarrhea, nausea, and vomiting, particularly in patients over 65 or those on medications that may cause volume depletion. The risk of depression and weight loss are also noted, with recommendations for regular monitoring and potential dose adjustments as needed. Otezla has not been studied in pregnant women, and potential risks should be communicated to expectant mothers.

Amgen's legacy of innovation continues as the company leverages technology and genetic data to develop treatments for cancer, heart disease, osteoporosis, inflammatory diseases, and rare conditions. The company remains a leader in the biotechnology industry, recognized for its contributions and advancements in medical science.