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Dyax/Sigma-Tau withdraw Kalbitor European market application

This article was originally published in Scrip

Executive Summary

Dyax, a bioterapeutics company based in Cambridge, MA, and partner Defiante Farmaceutica (a subisidiary of the Italian rare disease specialist, Sigma-Tau) are withdrawing their application for centralised marketing authorisation in Europe for Kalbitor (ecallantide) as a treatment of hereditary angiooedema (HAO). According to the partners, EMA’s CHMP indicated that the information provided was not sufficient to demonstrate a positive benefit-risk balance.



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