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news.The US Food and Drug Administration (FDA) has granted approval for the manufacture of drug substance anakinra for Swedish Orphan Biovitrum AB’s (Sobi) Kineret at Boehringer Ingelheim's microbial site in Austria.
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Kineret binds to the interleukin-1 type 1 receptor found in various tissues and organs and obstructs the biological activity of IL-1, which is a key mediator of inflammation and driver of autoinflammatory diseases.
Sobi CEO and president Geoffrey McDonough said that the FDA has approved the company’s technology transfer of Kineret manufacturing from Amgen to Boehringer Ingelheim.
"This completes the process and establishes our supply chain for the long term supply of Kineret," McDonough added.
Additionally, a Supplemental Biologics License Application (sBLA) has also been cleared by the FDA to allow the marketing of the drug in the US.
Kineret is a recombinant protein drug that is approved to treat the occurrence of Nomid in children and adults.