FDA approves Kineret for the treatment of NOMID
Sobi announced that the US Food and Drug Administration (FDA) has approved Kineret® (anakinra) for the treatment of children and adults with neonatal-onset multisystem inflammatory disease (NOMID). Kineret® is the FDA-approved therapy for NOMID, the most severe form of cryopyrin associated periodic syndromes (CAPS).
CAPS is, in its most severe form of NOMID, a life-long and severely debilitating disease. The disease is associated with an overproduction of an immune system protein known as interleukin-1 (IL-1). Untreated patients develop progressive hearing and vision loss, variable degrees of cognitive impairment and joint contractures. Treatment of NOMID patients for 5 years with Kineret demonstrated that, in addition to controlling the daily symptoms of the disease such as fever, rash, headache and joint pain, important central nervous system (CNS) functions such as hearing and vision remain stable and do not progress on treatment.
"In order to prevent organ damage that results from untreated disease, we have learned that early diagnosis and the initiation of IL-1 blocking therapy are critical," said Dr. Raphaela Goldbach-Mansky, the principal investigator of the NOMID study that was conducted at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), part of the National Institutes of Health (NIH) in Bethesda, MD, USA.
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