The US Federal Drug Administration (FDA) has received an application from Sobi for Kineret (anakinra) for the indication of neonatal-onset multisystem inflammatory disease (NOMID).
The filing is made under an Orphan Drug Designation for the indication cryopyrin associated periodic syndromes (CAPS), which was granted in 2010.
Sobi said it expects a review period of 6-8 months if the application is granted priority review.
The filing is based on a clinical trial conducted by principal investigator Raphaela Goldbach-Mansky at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), at NIH in Bethesda, Maryland.
The trial included a majority of NOMID patients in the US and has gathered extensive long-term treatment data.
Sobi CEO Geoffrey McDonough said this is an important step for curing infants, children and adults with NOMID.
"This is the outcome of a strong collaboration with the NIH and reflects our shared commitment to the orphan drug community and to supporting the pediatric rheumatology field," McDonough said.
