Ecallantide: its pharmacology, pharmacokinetics, clinical efficacy and tolerability

Abstract

Ecallantide (Kalbitor^®, Dyax Corporation) is a highly specific recombinant plasma kallikrein inhibitor developed for treatment of hereditary angioedema (HAE). Advantages of this agent over plasma-derived treatments are that it poses no risk of viral contamination, is highly selective, has a quick onset of action and can be administered subcutaneously. In clinical trials, ecallantide appears to be a safe and effective drug useful for the treatment of HAE patients suffering from an acute attack. Ecallantide was found to be superior compared with placebo in relieving symptoms, decreasing the severity of attacks and shortening the duration of attacks. The primary safety concern appears to be related to hypersensitivity reactions. Phase IV postmarketing surveillance studies to monitor the incidence of these reactions will be implemented by the company now that the drug has been US FDA approved.

Keywords::

• acute attacks
• anaphylaxis
• ecallantide efficacy
• hereditary angioedema
• immunogenicity
• kallikrein
• Pichia pastoris
• safety
• subcutaneous

Financial & competing interests disclosure

Jonathan A Bernstein is currently a Principal Investigator for Dyax and Shire studies and has also served as an Investigator for Cinryze, Berinert-P and Rhucin studies. He has served on a scientific advisory panel for Dyax Corporation and Lev Pharmaceuticals in the past. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.