Drug news
FDA accepts BLA for Rhucin as a treatment for HAE
The FDA has accepted for review the biologic license application (BLA) for Rhucin (recombinant human C1 esterase inhibitor) as a treatment for acute angioedema attacks in patients with Hereditary Angioedema.
The agency set 16 April 2014 as the Prescription Drug User Fee Act action date.
The BLA for Ruconest in HAE was based on data from a randomized placebo-controlled Phase III study, which was conducted under a special protocol assessment agreement with the FDA.
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