Bristol-Myers Squibb (NYSE:BMY) launched a subcutaneous administration option for Orencia, a biologic indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients who are at least 2 years old.
The prefilled syringe enables physicians, caregivers and patients to administer Orencia at home.
Orencia is traditionally administered via IV infusion.
“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,” Dr. Daniel Lovell, from the University of Cincinnati Medical Center, said in prepared remarks. “Importantly, subcutaneous abatacept also provides physicians a new administration option to offer their patients.”
In the company’s Phase III trial of subcutaneous Orencia, researchers evaluated the drug’s pharmacokinetics, efficacy and safety in patients ages 2 to 17 years old.
Bristol-Myers reported that the safety and immunogenicity for the subcutaneous formulation of Orencia were consistent with results from the study of intravenous Orencia. There were no cases of hypersensitivity reactions, according to the company, and local injection-site reactions occurred at a rate of 4.4%.
“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,” Brian Gavin, VP of Orencia development lead, said. “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.”
