Pharming submits amended Rhucin trial protocol to FDA
This article was originally published in Scrip
Executive Summary
Pharming has submitted an amended protocol to the US FDA for a Phase III trial of Rhucin (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE), after receiving "clarity" from the agency on requirements for US development of the product.