Pharming Submits Supplemental Biologics License Application to FDA for RUCONEST® for Prophylaxis of Hereditary Angioedema Attacks
Pharming Group N.V. today announced that it has submitted a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (“FDA”) 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 submission includes data from two completed trials of RUCONEST® for the prophylaxis of HAE attacks: a randomized, double-blind, placebo-controlled trial and an open-label study. The two studies enrolled a total of 56 patients and showed consistent efficacy and safety results.
“HAE patients in the US are currently facing a shortage of plasma-derived C1 inhibitor used to prevent attacks."- Bruno Giannetti - COO