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

 
• By Emily Hayes

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.

Pharming NV and Santarus Inc. have submitted a new BLA for Ruconest (recombinant human C1 esterase inhibitor) to FDA for treating acute hereditary angioedema attacks, but the delay from the initial filing means that if approved, the candidate would face a tough time as the fifth entrant to the U.S. market.

Pharming and Santarus announced the BLA submission for a 50 U/kg dose of the intravenously delivered candidate for acute angioedema attacks in HAE on April 17. HAE is a rare...

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