Swedish Orphan Biovitrum's Kineret® has Received Orphan Drug Designation in the USA
CAPS is a rare autoinflammatory condition with very severe symptoms and is potentially lethal. CAPS is characterized by excessive production of the endogenous inflammatory protein interleukin 1β (IL-1beta). Kineret® is a recombinant version of the naturally occurring IL-1 receptor antagonist which blocks the IL-1 receptor.
"The orphan drug designation (ODD) is an important step in our efforts to document Kineret for the severe and very debilitating disease CAPS. An ODD gives advantages in FDA assistance, user-fee benefits and, after orphan drug registration, seven years of market exclusivity. This will help us in our efforts to offer this potentially very valuable product to CAPS patients with high unmet medical needs." said Peter Edman, Ph.D., Chief Scientific Officer of Swedish Orphan Biovitrum.
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