FDA issues CRL on Ruconest sBLA

19 September 2018

Netherlands-based Pharming Group (Euronext: PHARM) saw its share plunge 29.05% to 0.69 euros by mid-morning today, after it revealed a further setback in its attempt to widen the use of its leading drug.

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL regarding the supplemental Biologics License Application (sBLA) for Ruconest (C1 Esterase Inhibitor [recombinant]) to expand the current indication to include prophylaxis in patients with hereditary angioedema (HAE).

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