Posted by Michael Wonder on 19 Sep 2018
Pharming receives complete response letter from FDA
19 September 2018 - Additional clinical trial data for prophylaxis of HAE requested.
Pharming announced today that it has received a complete response letter from the U.S. FDA regarding the supplemental biologics license application for Ruconest [C1 esterase inhibitor (recombinant)] to expand the current indication to include prophylaxis in patients with hereditary angioedema (HAE).
In November 2017, following feedback from FDA on two completed trials of Ruconest for prophylaxis of HAE attacks, Pharming filed an application to expand the approved indication. The Phase 2 studies, an open-label study and a randomised, double-blind, placebo-controlled trial with 4-8 week treatment periods, showed consistent efficacy and safety results.
