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FDA News Release

FDA approves expanded indications for Ilaris for three rare diseases

For Immediate Release:

The U.S. Food and Drug Administration today approved three new indications for Ilaris (canakinumab). The new indications are for rare and serious auto-inflammatory diseases in adult and pediatric patients:

  • Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS);
  • Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD); and
  • Familial Mediterranean Fever (FMF).

All three syndromes are hereditary diseases that are characterized by periodic attacks of fever and inflammation, as well as severe muscle pain. There are no previously approved therapies for TRAPS or HIDS/MKD.

“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,” said Badrul Chowdhury, M.D., Ph.D, director of the Division of Pulmonary, Allergy and Rheumatology Products in FDA’s Center for Drug Evaluation and Research.

Ilaris was previously approved for another periodic fever syndrome called Cryopyrin-Associated Periodic Syndromes (CAPS) and for active systemic juvenile idiopathic arthritis. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.

Approvals for the new indications were based on clinical studies, including safety, efficacy and pharmacokinetic data. The most common adverse reactions for these indications are injection site reactions and being more susceptible to catching colds.

Ilaris can cause serious side effects, including increased risk of serious infections. Ilaris can lower the immune system’s ability to fight infections. Other serious side effects include decreased ability to fight infections (immunosuppression) and allergic reactions. Patients experiencing any symptoms of an allergic reaction should call their healthcare provider, including: rash, itching and hives, difficulty breathing or swallowing, and dizziness or feeling faint. Patients should not get live vaccines if receiving Ilaris. Patients should not receive Ilaris if they are allergic to canakinumab or any of the ingredients in Ilaris.

Ilaris is manufactured and distributed by Novartis Pharmaceuticals Corporation, of East Hanover, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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