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EMEA grants Jerini marketing application for angioedema

German pharmaceutical company Jerini has had its Marketing Authorisation Application granted by the European Medicines Evaluation Agency  for Icatibant in the treatment of hereditary angioedema

German pharmaceutical company Jerini has had its Marketing Authorisation Application (MAA) granted by the European Medicines Evaluation Agency (EMEA) for Icatibant in the treatment of hereditary angioedema (HAE).

The agency's Committee for Medicinal Products for Human Use (CHMP) has also granted Jerini accelerated assessment for the review of this submission, which shortens the regulatory review period from 210 to 150 calendar days and is granted to drug candidates addressing major public health interest and therapeutic innovation.

Hereditary angioedema (HAE) is a rare, potentially fatal genetic disorder typified by a deficiency or dysfunction of the plasma protein C1 Inhibitor, and characterised clinically by swelling of the extremities, face, trunk, abdominal viscera, and upper airway.

The start of Jerini's EMEA regulatory review period begins on August 15, 2007, and an opinion from the agency's committee could be received as early as first quarter 2008. EMEA approval provides marketing authorization in all 27 EU member states as well as Norway, Iceland, and Liechtenstein.

Jens Schneider-Mergener, CEO of Jerini, said of the acceptance: "This milestone along with our accelerated assessment status provides clarity for our regulatory timeline moving forward. Jerini is very confident that we can provide HAE patients with an exciting new treatment concept in the near future. Icatibant is the first-in-class bradykinin antagonist which, when approved, will enable this patient group to better manage their disease, thereby improving their quality of life."

16th August 2007

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