FDA expands approval of abatacept for children with psoriatic arthritis
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Key takeaways:
- The FDA has approved abatacept for the treatment of psoriatic arthritis in patients aged 2 years and older.
- The approval is based on data from pediatric patients with polyarticular juvenile idiopathic arthritis.
The FDA has approved a supplemental biologics licensing application from Bristol Myers Squibb expanding the indication of abatacept to include children aged 2 years and older with psoriatic arthritis, according to a company press release.
“The FDA’s approval of expanding Orencia’s indication adds a much-needed treatment option for children with juvenile psoriatic arthritis, a rare, potentially serious condition characterized by chronic inflammation and joint damage,” Carlos Dortrait, senior vice president of U.S. Immunology at Bristol Myers Squibb, said in the release. “This important milestone represents the latest advance in Orencia’s 18-year legacy in arthritis, reinforcing BMS’ commitment to combatting immune-mediated diseases and helping to improve the lives of patients with chronic diseases.”
According to the company, the approval of abatacept (Orencia, Bristol Myers Squibb) in patients aged 2 to 17 years with PsA was based on “adequate and well-controlled” studies of the drug in adults with PsA, as well as pharmacokinetic data from adults with rheumatoid arthritis, adults with PsA and children with polyarticular juvenile idiopathic arthritis. Safety data were derived from clinical studies of children aged 2 to 17 years with polyarticular JIA, who received a subcutaneous formulation of abatacept.
Based on these data, the observed concentrations of abatacept in the blood immediately before the next dose are generally comparable between adults with PsA and children with JIA with active polyarthritis, according to the release. In addition, pharmacokinetic exposure is expected to be comparable between adults and children with PsA, the company said in the release.
The FDA initially approved abatacept for moderate to severe RA in 2005, and later for adults with active PsA in 2017.
“Children living with psoriatic arthritis can experience a number of challenging symptoms including swollen and painful joints,” Steven Taylor, president and CEO of the Arthritis Foundation, said in the release. “The FDA’s approval of Orencia for juvenile PsA in patients 2 years of age and older means another treatment option is available to manage this rare chronic disease, which is exciting news for the arthritis community of young patients, their caregivers and health care professionals.”
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