Pharming Group N.V. announced 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.
Pharming announces conclusion of FDA End of Phase 2 interactions on RUCONEST® for Prophylaxis of HAEMonday, September 11, 2017
Based on the feedback from the FDA, Pharming will submit a BLA supplement (sBLA) to the FDA for review in Q4 of this year, which will include routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE) as an expanded indication for RUCONEST®.
Dr. Bruno Giannetti, MD, Chief Operations Officer of Pharming, commented: “We look forward to continuing to work with the FDA to expand treatment options with RUCONEST® for HAE patients.”