About the API
Icatibant acetate is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults. HAE is a rare, potentially life-threatening disease characterized by intermittent and unpredictable attacks of sudden swelling involving various organs.
Overactivation of the naturally-occurring bradykinin peptide is thought to play a central role in the localized swelling, inflammation, and pain characterizing HAE. Icatibant is a synthetic analogue of bradykinin, and reduces its activity by binding to cell receptors in its stead. Icatibant acetate is self administered through subcutaneous injectable in the abdominal area.
Icatibant acetate was approved in the EU in 2008 and in the US in 2011, under the trade name Firazyr.
It received orphan drug status in the US, Australia, EU and Switzerland. A synthetic peptidomimetic drug, it is prepared through multi-step chemical synthesis.