FDA Clears Orencia for Use In Children Ages 2 and Up

June 9, 2017

Previously, the drug was only approved for patients ages 6 and up.

The U.S. Food and Drug Administration (FDA) has expanded the use of Orencia, a subcutaneous drug for patients with moderate to severe active polyarticular juvenile idiopathic arthritis (JIA), to include patients ages 2 and up.

Bristol-Myers Squibb, the manufacturer of the drug, announced the approval on Thursday in a news release.

Previously, Orencia IV was the first FDA-approved IV biologic for patients ages 6 and up with moderately to severely active polyarticular JIA. The manufacturer produces the drug in pre-filled syringe form, allowing patients to administer it at home.

Researchers scrutinized the efficacy of Orencia in an open-label, phase 3 study with a 4-month short-term period, combined with a 20-month open-label extension period. The study involved patients ages 2-17, all of whom were diagnosed with JIA and had not responded well to minimally one nonbiologic or biologic disease-modifying, anti-rheumatic drug.

After 4 months, JIA ACR 30, 50 and 70 response rates were 81%, 71% and 53%, respectively. These results were consistent with the IV study, JIA-1.

“The data supporting this new FDA approved prefilled syringe provide a scientific basis for the dosing, efficacy and safety of subcutaneous abatacept in JIA and add to the growing body of clinical evidence for patients 2 years of age and older living with this difficult autoimmune disease,” said Daniel J. Lovell, M.D., M.P.H., Joseph E. Levinson Endowed Chair of Pediatric Rheumatology and Professor of Pediatrics, University of Cincinnati Medical Center. “Importantly, subcutaneous abatacept also provides physicians a new administration option to offer their patients.”

Adverse events in the trial were like those that manifest in adults. During the JIA-1 study, 70% of participants experienced adverse events during the 4-month, lead-in, open-label period of the study. Thirty-six percent of patients experienced infections. Patients exhibited headache, nausea, diarrhea, cough, pyrexia and abdominal pain in 5% of cases.

Bristol-Myers Squibb notes that Orencia can be used alone or in conjunction with methotrexate, though it should not be used concomitantly with TNF antagonists. It is also not recommended for use with other biologic RA therapies.

It remains unknown whether Orencia is safe to use in children less than 2 years of age, and intravenous administration hasn’t been student in patients less that 6 tears of age. Bristol Myers-Squibb, in its news release, says Orencia should be initiated without an IV loading dose and delivered once weekly according to weight-tiered dosing. The company adds that patients will need to be educated as to how to prepare and inject the drug.