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12:00 AM
 | 
Sep 25, 2006
 |  BioCentury  |  Product Development

Jerini: Preponderance matters

Despite missing the primary endpoint in one of its two Phase III trials of Icatibant to treat hereditary angioedema, Jerini AG and U.S. marketing partner Kos Pharmaceuticals Inc. think the Phase III data will be sufficient for marketing authorization in Europe and potentially the U.S.

In Europe, according to Jerini, there is little doubt the data package could fulfill the requirements for regulatory approval, because EMEA only requires data from one trial, FAST-2, which met its primary endpoint.

In the U.S., where two pivotal trials are required and where Jerini had an SPA, the situation is not as clear now that FAST-1 has missed its primary benchmark.

Icatibant, a selective peptidomimetic bradykinin B2 receptor antagonist, met the primary endpoint of time to onset of symptom relief versus tranexamic acid in the double-blind, European and Israeli FAST-2 trial in 74 patients (p<0.001).

It missed the...

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