Swedish Orphan Biovitrum AB (publ) (Sobi), a Sweden-based biopharmaceutical company, has received approval for its Kineret (anakinra) from the Russian Federation's Ministry of Health, it was reported on Tuesday.
The product is intended for the treatment of Cryopyrin associated periodic syndromes (CAPS). It is an interleukin-1 receptor antagonist that is indicated in the US for the reduction in signs and symptoms and for slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs) and for the treatment of neonatal-onset multisystem inflammatory disease (NOMID), a form of CAPS. CAPS are a group of rare genetic autoinflammatory diseases causing a number of inflammatory responses such as fever, pain sensitization, bone and cartilage destruction and acute plasma protein responses.
Norbert Oppitz, head of Immunology and International at Sobi, stated: "We are excited to announce the approval of this important treatment and we look forward to serving patients with Cryopyrin associated periodic syndromes in Russia. Today's announcement also marks a significant milestone for Sobi's future ambition, as Russia is a key market for our geographic expansion strategy over the next five years."
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