Pharming announces FDA Acceptance for Review of Supplemental Biologics License Application for RUCONEST® for Prophylaxis of Hereditary Angioedema Attacks

Wednesday, January 17, 2018

Pharming Group N.V. 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.

RUCONEST® is currently approved for the treatment of acute attacks in adult and adolescent patients with HAE. If approved for this new indication, RUCONEST® would become the first C1 inhibitor therapy that would be approved for both acute treatment and prophylaxis of HAE attacks.

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