Pharming Receives Complete Response Letter from FDA
(WorldNews Netherlands)

Additional clinical trial data for prophylaxis of HAE requested Leiden, The Netherlands, 19 September 2018, Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM) announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) 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). In November 2017, following feedback from FDA on two completed trials of RUCONEST® for prophylaxis of HAE attacks, Pharming filed an sBLA to expand the approved...