FDA approves first therapy for paediatric psoriasis treatment
pharmafile | November 7, 2016 | News story | Sales and Marketing | Amgen, Enbrel, paediatric, psoriasis
Amgen’s Enbrel has been given approval by the FDA for expanded use to treat children with chronic moderate-to-severe plaque psoriasis. This is the first such approval for the systemic therapy to treat paediatric patients from ages 4 to 17.
The approval was based on the results of a Phase III one-year study and a five-year open-label extension study that evaluated the safety and efficacy of Enbrel in patients aged from 4 to 17, who were suffering from chronic moderate-to-severe plaque psoriasis. The drug was found to be effective and did not demonstrate side-effects unobserved in previous studies that contained adults.
“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, executive vice president of research and development at Amgen.
He continued, “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.”
Enbrel is one of Amgen’s biggest earners but has struggled to see its volume grow. This has led to increases in the price of the drug to make up for the lack of volume, with the price increasing from $10,000 a year to $48,000 a year. This expanded approval will help Amgen potentially reach more patients.
Ben Hargreaves
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