The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion to Abbvie‘s Humira (adalimumab) for the treatment of chronic non-infectious anterior uveitis in pediatric patients who are at least 2 years old.
More than 75 percent of cases of pediatric anterior uveitis occur in children with juvenile idiopathic arthritis (JIA).
Humira is indicated for children who do not respond to, or do not tolerate, conventional therapy, or for whom conventional therapy is not appropriate.
If approved — a marketing authorization decision is expected in September — sales of Humira for this indication will be authorized in all 28 member states of the European Union, as well as in Iceland, Liechtenstein, and Norway.
Uveitis is an inflammation of the uvea, a membrane in the eye that includes the iris, the choroid, and the ciliary body. The condition can cause severe vision loss, which occurs in 25 to 30 percent of pediatric uveitis cases, making early diagnosis and treatment essential.
CHMP’s positive opinion is based on findings from the SYCAMORE clinical trial in the United Kingdom, a randomized, controlled trial assessing the safety, clinical effectiveness, and cost effectiveness of Humira for the treatment of JIA-associated uveitis in children and adolescents ages 2 years or older.
The trial tested 90 children with severe uveitis who received methotrexate with Humira (30 children) or without it (60 children). Patients received the therapies until treatment failure or until 18 months had elapsed. After 18 months, all children were followed up for an additional six months for a total of two years.
Treatment with Humira in addition to methotrexate delayed the time elapsed before treatment failure, compared with methotrexate treatment alone. Researchers also observed a higher percentage of treatment failures among patients in the placebo group (60 percent), compared to patients in the Humira group (27 percent).
There were more adverse events reported in the group treated with Humira.
“Today’s positive CHMP opinion marks a significant milestone for pediatric uveitis patients and their caregivers,” Marek Honczarenko, vice president, immunology development at AbbVie, said in a press release.
“When Humira’s label is expanded to include chronic non-infectious anterior uveitis it will provide an important new treatment option for children from 2 years of age living with this serious and potentially blinding condition, especially for those patients who have failed standard treatments. It is also a reflection of AbbVie’s commitment to provide therapies for both adult and pediatric patients living with immune-mediated diseases,” Honczarenko added.
Humira was approved by the EMA for the treatment of some noninfectious forms of uveitis in adults in June 2016.
“Childhood uveitis is a challenging condition often associated with delays in diagnosis and high morbidity,” said Prof. Athimalaipet Ramanan, pediatric rheumatologist at University Hospitals Bristol NHS Trust and principal investigator of the SYCAMORE study.
“The clinical trial data demonstrate that Humira has the potential to help thousands of children preserve their eyesight from the ocular complications associated with chronic noninfectious anterior uveitis,” Ramanan added.