Leaders with the U.S. Food and Drug Administration (FDA) recently expanded its approval of Ilaris to include three new indications of rare diseases for adult as well as pediatric patients.
These rare and serious auto-inflammatory diseases include Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) and Familial Mediterranean Fever (FMF).
All of these health conditions are hereditary illnesses. They manifest in periodic bouts of inflammation, fever and severe muscle pain. Unfortunately, no therapies have been approved for TRAPS or HIDS/MKD.
Ilaris previously received approval for Cryopyrin-Associated Periodic Syndromes (CAPS) and active systemic juvenile idiopathic arthritis. New approvals require clinical studies that evaluate the effectiveness, safety and pharmacokinetic data.
Health care experts are asked to look at labeling and prescription information before prescribing the new treatment to patients. Common side effects include injection site reactions and greater susceptibility to catching colds.
“For the first time, patients with TRAPS and HIDS/MKD, two painful and life-altering diseases, have access to a treatment that may help improve their quality of life,” Dr. Badrul Chowdhury, Division of Pulmonary, Allergy and Rheumatology Products director in the FDA's Center for Drug Evaluation and Research, said.
