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Pharming/Santarus’ Recombinant HAE Drug Ruconest Goes Back To FDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

A BLA has been re-submitted to FDA for Ruconest, which is differentiated from other C1 esterase inhibitors by its recombinant structure. But as the fifth drug for the rare hereditary angioedema condition in the U.S. market, commercial expectations are low.

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