FDA approves SOBI's Kineret for the treatment of NOMID

Biotech firm Swedish Orphan Biovitrum (STO: SOBI) today announced that the US Food and Drug Administration has approved Kineret (anakinra) for the treatment of children and adults with neonatal-onset multisystem inflammatory disease (NOMID).

Kineret, discovered by US biotech giant Amgen (Nasdaq: AMGN), is the first and only FDA-approved therapy for NOMID, the most severe form of cryopyrin associated periodic syndromes (CAPS). The drug was cleared by the FDA and other regulators for the reduction in signs and symptoms of moderately-to-severely-active rheumatoid arthritis in adult patients as far back as 2001.

This is the first approval allowing the use of Kineret in children. Kineret was approved for NOMID under an Orphan Drug designation. A priority review was granted by the FDA based on the product's potential to provide a significant advance in therapy for the NOMID patient population where no adequate therapy exists. SOBI will provide a prefilled syringe with a graduated label to allow flexible dosing in children.