US FDA refuses to file Rhucin BLA
This article was originally published in Scrip
Executive Summary
Pharming and Santarus are bracing themselves for a six-to-nine month delay in receiving US marketing approval for Rhucin (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE) after receiving a "refusal to file" letter from the US FDA.