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FDA approves Dyax's lead drug, Kalbitor

Dyax has announced that the US FDA has approved Kalbitor (ecallantide) for the treatment of hereditary angioedema (HAE)

Dyax has announced that the US Food and Drug Administration (FDA) has approved Kalbitor (ecallantide) for the treatment of the rare, genetic disorder hereditary angioedema (HAE) in patients 16 years of age and over.

The approval of Kalbitor is based on evidence from two placebo-controlled phase III trials. Patients were able to participate in both trials, resulting in a total of 143 unique patients being involved.

HAE is a rare, genetic disorder resulting in attacks of severe, debilitating and often painful swelling to the face, hands, feet, abdomen and airway. It also affects the gastrointestinal tract and genitalia.

Kalbitor is the first subcutaneous treatment for all acute HAE attack locations to be approved in the US. As part of the approval, Dyax has worked with the FDA to produce a Risk Evaluation and Mitigation Strategy (REMS) programme. The programme will communicate the risk of anaphylaxis – a side effect experienced by 2.7 per cent of patients receiving the treatment subcutaneously during the clinical trials. Patients will also receive information to enable them to distinguish hypersensitivity reactions from  HAE attack symptoms.

Professor Jonathan Bernstein, department of internal medicine, division of immunology/allergy, at the University of Cincinnati College of Medicine said: "The subcutaneous route of administration and efficacy in treating acute attacks in patients 16 years of age and older, regardless of anatomic location, make Kalbitor an important treatment option."

Kalbitor will be the first drug marketed by US-based drug company. Dyax also runs its Licensing and Funded Research Programme (LFRP), which allows other companies to access to their patented drug discovery technology, phage display through various types of licenses and collaborations.

The intravenous therapy Cinryze, produced by ViroPharma, is approved as a preventative treatment for angioedema attacks. In October 2009, the FDA approved CSL Behring's Berinert for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE).

3rd December 2009

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