FDA Acceptance for Review of sBLA for Ruconest

The U.S. Food and Drug Administration (FDA) has accepted for review Pharming Group N.V.’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 HAE. The FDA has indicated that the sBLA is sufficiently complete to permit a substantive review and has set an action date of 21 September 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.
(Source: Pharming)

2018-01-19T12:21:20+00:00