Operational updates
Pharming announces FDA Acceptance for Review of Supplemental Biologics License Application for RUCONEST® for Prophylaxis of Hereditary Angioedema Attacks
Pharming Group N.V. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Pharming’s supplemental Biologics License Application (sBLA) for RUCONEST® [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult and adolescent patients with hereditary angioedema (HAE).
The FDA has indicated that the sBLA is sufficiently complete to permit a substantive review and has set an action date of September 21, 2018.