Pharming announces conclusion of FDA End of Phase 2 interactions on RUCONEST® for Prophylaxis of HAE
Pharming announced today that it has concluded its End-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA).
As part of these interactions, Pharming provided the FDA with the results of two completed Phase 2 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.
“We look forward to continuing to work with the FDA to expand treatment options with RUCONEST® for HAE patients.”- Dr. Bruno Giannetti, Pharming’s COO