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.