The First Shall Be Fifth: Salix’s Recombinant C1 Esterase Inhibitor Enters Crowded HAE Market
This article was originally published in The Pink Sheet Daily
Ruconest must compete with four other HAE therapies approved by FDA since 2008, including a pair of human plasma-derived C1 esterase inhibitors.
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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.
FDA’s Aug 25 approval of Shire PLC’s Firazyr (icatibant) for acute treatment of attacks of hereditary angioedema, with a label that allows patients to self-administer the drug, puts a convenience advantage up against a first-to-market advantage for the well-established C-1 esterase inhibitors.
As more companies of all sizes embrace rare diseases – lured in part by supposed lower regulatory and reimbursement hurdles – some niche markets are beginning to look rather busy.