Shire To Test Convenience Versus Familiarity In HAE With Approval Of Firazyr
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.
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Ra hopes to launch a Phase III program for zilucoplan next year, with a goal of bringing an alternative therapy for MG patients into competition with Alexion’s Soliris.
Ruconest must compete with four other HAE therapies approved by FDA since 2008, including a pair of human plasma-derived C1 esterase inhibitors.
Shire is buying ViroPharma at a steep premium to acquire its pipeline assets, notably C1 esterase inhibitor Cinryze, which the London-listed specialty pharma plans to expand internationally, initially to treat hereditary angioedema and later for other rare diseases.