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.