Ilaris Approved for Adult Onset Still’s Disease
On June 16, 2020, the FDA approved a biologics license application (BLA) for Ilaris (canakinumab; Novartis) for the treatment of active adult-onset Still’s disease. Ilaris was previously approved for multiple other indications, including familial cold autoinflammatory syndrome, Muckle-Wells syndrome, tumor necrosis factor receptor associated periodic syndrome in adult and pediatric patients, hyperimmunoglobulin D syndrome/mevalonate kinase deficiency in adult and pediatric patients, familial Mediterranean fever in adult and pediatric patients, and active systemic juvenile idiopathic arthritis in patients aged 2 years and older. More Information.
De Novo Clearance Granted for ADHD Device
On June 15, 2020, the FDA granted de novo marketing clearance for the prescription-only EndeavorRx device (Akili Interactive), the first game-based digital therapeutic device to improve attention function in children with attention deficit hyperactivity disorder (ADHD). EndeavorRx is indicated for pediatric patients aged 8 to 12 years with primarily inattentive or combined-type ADHD who have demonstrated an attention issue. The device is intended for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. More Information.
Endologix Inc. Recalls Ovation iX Abdominal Stent Graft Systems
The FDA announced a Class I recall of the Ovation iX abdominal stent graft systems (Endologix Inc.) due to risks of liquid polymer leaks during implantation. The Ovation iX abdominal stent graft system is intended to treat patients with abdominal aortic or aortoiliac aneurysms (AAA). More Information.