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Icatibant fails to get FDA approval

German pharmaceutical company, Jerini, has revealed that the US Food and Drug Administration has not approved its hereditary angioedema medication, Icatibant
German pharmaceutical company, Jerini, has revealed that the US Food and Drug Administration (FDA) has not approved its hereditary angioedema (HAE) medication, Icatibant.

Icatibant has been granted orphan drug status by the FDA and European Medicines Agency (EMEA) but has failed to meet approval standards for use in the US market. The FDA issued Jerini with a non-approvable letter and the company announced on April 24 that it plans to address the agency's concerns at the earliest opportunity. Details of the FDA's questions about the efficacy of Icatibant as a HAE treatment have not yet been published.

Jens Schneider-Mergener, chief executive officer of Jerini, said: "It is extremely unfortunate that patients in the US will not have access to icatibant in order to treat this debilitating and potentially life-threatening disease as quickly in Europe."

It is estimated that between 15,000 and 75,000 people in the US and Europe are affected by HAE, a condition that can cause severe swelling of the larynx, which can lead to constriction of the upper airways.

Icatibant has, however, been granted a positive opinion by the EMEA's Committee for Medicinal Products for Human use (CHMP), which it recommended that the drug receive marketing authorisation. A decision on whether to approve Icatibant for use is expected from the European Commission within 67 days from adoption of the opinion.

Dr Mathew Helbert, consultant immunologist at the Manchester Royal Infirmary, said: "This news will be particularly exciting for both patients with HAE and those clinicians who treat them as there has been no new treatment for HAE for more than 20 years."

"As a subcutaneous injection, icatibant has the potential to improve tolerability by an order of magnitude for patients," he concluded.

Dr Hilary Longhurst, consultant immunologist in the department of immunology at Barts and the London NHS Trust, said: "It's very good news that the CHMP has reacted positively to icatibant. We currently have a very limited range of medicines with which to treat this extremely unpleasant condition and there is a real need for new developments."

28th April 2008

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