Arpida withdraws EU marketing authorization for Mersarex

The European Medicines Agency (EMEA) has been formally notified by Swiss biotechnology firm Arpida A/S (now in the throes of a merger with fellow Switzerland-based Evolva) of its decision to withdraw its application for a centralized marketing authorization for the medicine Mersarex (iclaprim), 12.8mg/ml concentrate for solution for infusion.

Early this year, the US Food and Drug Administration says it needs more evidence of efficacy before it can approve iclaprim for its intended claim of the treatment of complicated skin and skin structure infections (The Pharma Letter January 26).

The European application for Mersarex was submitted to the Agency on July 25, 2008. At the time of the withdrawal, it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP).

In its official letter, the company stated that the withdrawal of the application was based on the CHMP's view that the data provided did not allow the Committee to conclude on a positive benefit-risk balance for Mersarex.