3 April 2017 - Breakthrough therapy designation recognises the major potential therapeutic benefits of tadekinig alfa in the treatment of severe and potentially fatal auto-inflammatory conditions.
AB2 Bio today announced that the US FDA has granted breakthrough therapy designation to tadekinig alfa in the treatment of monogenic, IL-18 associated auto-inflammatory conditions with ongoing systemic inflammation.
In addition, the FDA has also granted orphan drug designation to Tadekinig alfa for the treatment of haemophagocytic lymphohistiocytosis.