Bristol-Myers Squibb recently announced that a new U.S. Food and Drug Administration (FDA)-approved formulation of Orencia (abatacept) is now available for patients with moderate to severely active polyarticular juvenile idiopathic arthritis.
The subcutaneous treatment is available for patients ages 2 and older. Because this new Orencia treatment is available as a prefilled syringe, it allows the treatment to be performed at home.
The dosage needs to be determined by a physician, and patients or caregivers must receive training on how to correctly prepare and inject Orencia.
“The data supporting this new FDA-approved prefilled syringe provide a scientific basis for the dosing, efficacy and safety of subcutaneous abatacept in JIA [juvenile idiopathic arthritis] and add to the growing body of clinical evidence for patients 2 years of age and older living with this difficult autoimmune disease,” Daniel J. Lovell, MD, the Joseph E. Levinson Endowed Chair of Pediatric Rheumatology and a professor of pediatrics at the University of Cincinnati Medical Center, said in a press release.
“Importantly, subcutaneous abatacept also provides physicians a new administration option to offer their patients,” Lovell said.
Orencia can be administered alone, called monotherapy, or combined with Trexall (methotrexate), a disease-modifying treatment for some autoimmune diseases, including arthritis.
However, Orencia is not approved for use in combination with antagonists of tumor necrosis factor (TNF), a key component of systemic inflammation, or with other biologic rheumatoid arthritis therapeutics, such as Kineret (anakinra).
“Juvenile idiopathic arthritis can cause pain, stiffness and swelling that may make it difficult for children to do everyday things like playing with friends or riding a bike. Understandably, the condition can impact the entire family,” said Brian J. Gavin, vice president, Orencia Development Lead at Bristol-Myers Squibb.
“We’re proud to be able to provide a new subcutaneous administration option for Orencia, a proven choice for patients with JIA, as part of our commitment to advancing immunoscience research to address unmet needs and supporting JIA patients and their families,” Gavin added.
Juvenile idiopathic arthritis is the most common type of arthritis in children. The condition is estimated to affect more than 50,000 children in the United States. It can affect one or several joints, potentially compromising the child’s ability to perform everyday tasks.