Sobi has filed an application for Kineret® (anakinra)
with the FDA for NOMID
The NOMID Alliance has been advocating for patients as part of this effort for a several years.
No ruling has been made yet by the FDA.
STOCKHOLM, SWEDEN--(Marketwire -07/06/12)-
Sobi has filed an application for Kineret® (anakinra) for the indication of neonatal-onset multisystem inflammatory disease (NOMID) with the Federal Drug Administration (FDA) in the US. The filing is made under an Orphan Drug Designation for the indication cryopyrin associated periodic syndromes (CAPS), which was granted in 2010. If the application is granted priority review, Sobi expects a review period of 6-8 months....
"The awareness and understanding of NOMID has increased significantly in the last couple of years", said Mrs. Karen Durrant, President of The NOMID Alliance -- a non-profit organization for patients with CAPS and other autoinflammatory diseases. "However, there is still an unmet medical need for these severely ill patients and an FDA approved therapy for this drug would greatly facilitate access to reimbursed medication."
To read the rest of the press release, go to this link