Cinryze "complete response" letter means HAE race is still on
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA's "complete response" letter to ViroPharma regarding its supplemental Cinryze filing for treatment of acute attacks of hereditary angioedema requests an additional clinical trial, stalling the firm's progress in a race with two other C1 esterase inhibitors to be the first acute HAE treatment approved in the U.S. ViroPharma said June 4 that FDA believes the placebo-controlled trial submitted in support of the sBLA "lacked robustness." Cinryze, which was first to market with a prophylaxis claim, is now in the same boat as CSL Behring's C1 esterase inhibitor Berinert: CSL received a "complete response" letter Dec. 5, 2008 requesting another trial. A filing for the third C1 candidate, Pharming's Rhucin, is expected in September. Pharming said March 31 that it is conducting additional data analyses at FDA's behest
You may also be interested in...
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.
Takeda, Astellas Found New JV To Support Japanese Bioventures
Major Japanese companies Takeda, Astellas and SMBC are joining hands to establish a new joint venture with $3.9m capital and based in Japan’s largest biocluster Shonan iPark to help incubate local biopharma start-ups.
Could Eledon’s Anti-CD40L Change Transplant Medicine?
Eledon Pharmaceuticals’ CD40 Ligand blocker has yielded impressive results for post-transplant immunosuppression and cutting-edge transplant doctors have also used it for pig-to-human kidney and heart transplants, opening up the field of xenotransplantation.