Icatibant
About Icatibant
Icatibant offers a novel treatment for HAE. The European Commission has granted the company marketing authorization for Firazyr® (Icatibant) in the treatment of acute attacks of HAE, which allows Jerini to market Firazyr® in the European Union’s 27 member states, making it the first product to be approved in all EU countries for the treatment of HAE. Jerini’s sales and marketing teams are ready to launch the product in the third quarter of 2008.Icatibant - A Specific Bradykinin Blocker
Icatibant is a potent and highly specific competitive bradykinin B2 receptor antagonist. Bradykinin is a peptide hormone, often produced in response to trauma, which increases vascular permeability, dilates blood vessels, contracts non-vascular smooth muscle cells, and is a powerful mediator of pain. When produced in excess, bradykinin causes typical symptoms of inflammation, including swelling, reddening, warmth, and pain, which are mediated through the bradykinin B2 receptors.Excessive bradykinin levels have been demonstrated in several diseases, including HAE and other forms of angioedema, severe liver diseases, burn injuries, and in allergic or inflammatory conditions. Icatibant’s high potency and specificity as a bradykinin B2 receptor antagonist support the strong scientific rationale for its use in the treatment of acute HAE attacks and other inflammatory diseases.
Icatibant and hereditary angioedema (HAE)
HAE is a debilitating and potentially life-threatening genetic disease characterized by spontaneous and recurring attacks of edema (swelling) in various parts of the body. HAE attacks affecting the hands, face and feet can be disfiguring, whereas abdominal attacks, caused by the swelling of the intestinal wall, can cause severe pain. Attacks affecting the throat can be fatal, as swelling can lead to suffocation. Patients suffer an average of 12 attacks per year, each lasting about two to five days if left untreated. Although approximately 10,000 patients in the US and EU have been diagnosed with HAE, the disease is believed to be severely under-diagnosed. No adequate treatment is currently available for HAE in the US, and an intravenously administered blood product is marketed in a limited number of countries. Read more about HAE.Icatibant and drug-induced angioedema
Hereditary angioedema is one of several forms of angioedema. Another form of the disease is known to be associated with the use of blood pressure medication, while others occur without any known cause. Jerini plans to broaden the therapeutic potential of Icatibant by addressing additional disease indications in which the pathophysiological role of elevated bradykinin levels has been established, and plans to begin a Phase II proof of concept clinical trial of Icatibant in the treatment of drug-induced angioedema in 2008.Capillary Leak Syndrome
Capillary Leak Syndrome (CLS) is a frequent complication in severe burn and sepsis. Due to the progressive loss of intravasal fluids, patients develop generalized edema and hemodynamic instability frequently leading to organ failure, cardiovascular collapse and death. Current treatment options for CLS in severe burn and sepsis are inadequate. Icatibant is a promising treatment option based on its proven ability to block the vascular permeability increase in patients. Icatibant is currently being tested in several preclinical CLS models.Publications
Konrad Bork, MD,a Jorge Frank, MD,b Boris Grundt, MD,a Peter Schlattmann, MD, MSc,c Juerg Nussberger, MD,d and Wolfhart Kreuz, MDe Mainz, Berlin, and Frankfurt, Germany, Maastricht, The Netherlands, and Lausanne, Switzerland. Treatment of acute edema attacks in hereditary angioedema with a bradykinin receptor-2 antagonist (Icatibant) J Allergy Clin Immunol. 2007 Jun;119(6):1497-503. Epub 2007 Apr 5.M. Bas, H. Bier, J. Greve, G. Kodja, T.K. Hoffman Novel pharmacotherapy of acute hereditary angioedema with bradykinin B2 receptor antagonist Icatibant. 2006 Dec;61(12):1490-2. In press.



