FDA Expands Enbrel Indication to Children with Psoriasis
Enbrel is now indicated in pediatric patients with moderate-to-severe plaque psoriasis.
Amgen recently announced that the FDA has approved a supplemental Biologics Application for the use of Enbrel in children with psoriasis.
This expanded indication makes Enbrel the only systemic therapy approved to treat pediatric patients with this condition, Amgen reported in a press release.
"As many parents of children with moderate-to-severe plaque psoriasis can tell you, there is a need for FDA approved systemic therapies in the pediatric setting. Until now, no biologics — which are effective in treating adults with moderate-to-severe plaque psoriasis — had been approved in the US for the treatment of moderate-to-severe plaque psoriasis in children," said Randy Beranek, president and chief executive officer of the National Psoriasis Foundation. "This new approval is an important development for this patient community, as well as their parents and families, and marks a significant milestone in advancing the treatment of children living with this devastating disease."
There are approximately 125 million patients with psoriasis worldwide, and one-third of those cases are in pediatric patients.
This recent approval was based on positive results from a phase 3 clinical trial investigating the drug among patients 4- to 17-years-old with chronic moderate-to-severe plaque psoriasis. In the 5-year open-label extension study, investigators found that Enbrel was very effective in treating these patients.
Adverse events reported in the study were similar to those that occur in adults treated with Enbrel, according to Amgen. Common adverse reactions include injection site reaction and infection, which were seen across all indications. Infections reported by pediatric patients were typically mild.
Enbrel is a soluble form of a tumor necrosis factor receptor that is administered through an injection. The drug received its first approval in 1998 for use in patients with moderate-to-severe rheumatoid arthritis. For these patients, Enbrel can be used as a monotherapy or in combination with methotrexate.
It is also indicated in patients aged 2 years and older who have moderate-to-severe polyarticular juvenile idiopathic arthritis. Additionally, it can reduce the signs and symptoms, stop the progression of damage of arthritis, and improve physical function in patients with psoriatic arthritis, according to Amgen.
Enbrel has also been approved for use in patients with active ankylosing spondylitis.
"The need for an effective treatment for chronic moderate-to-severe pediatric psoriasis patients is high, and safety is always a concern when it comes to treating children. Enbrel has over a decade of experience in adult moderate to severe plaque psoriasis, and that proven track record matters to healthcare professionals, as well as the parents of children with moderate-to-severe plaque psoriasis," said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. "Today's FDA approval shows that innovation doesn't stop with a drug's first market approval, and further reflects Amgen's commitment to continually unlock and expand the therapeutic potential of our medicines in the hopes of filling unmet patient needs."