Posted by Michael Wonder on 29 Nov 2017
Pharming submits supplemental biologics license application to FDA for Ruconest for prophylaxis of hereditary angioedema attacks
27 November 2017 - Submission based on positive results from two clinical trials.
Pharming Group announced today that it has submitted a supplemental biologics license application to the U.S. 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 randomised, 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.
