FDA turns down 'incomplete' Rhucin dossier
Dutch biotechnology company Pharming and its marketing partner Santarus have suffered a setback in their bid to bring hereditary angioedema treatment Rhucin (conestat alfa) to the US market.
The US Food and Drug Administration (FDA) issued a "refusal to file" indicating that the Biologics License Application filed by the companies "was not sufficiently complete to enable a critical medical review."
Analyst Scott Henry of Roth Capital Partners believes that the decision means that approval of Rhucin will be delayed by six to 12 months, with a similar delay for a $5 million milestone payment from Santarus to Pharming, according to Reuters.
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