Pharming/Santarus’ Recombinant HAE Drug Ruconest Goes Back To FDA
This article was originally published in The Pink Sheet Daily
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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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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Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.