The biologics license application (BLA) submission is based on data from the company’s pivotal Phase III acute trial which met its protocol-defined, pre-specified primary endpoint with statistical significance as reported on March 14, 2007. Additional details regarding the acute study results will be presented at the 2007 Annual Meeting of the American College of Allergy, Asthma & Immunology in November.
Lev is also developing Cinryze for the prophylactic treatment of hereditary angioedema (HAE), for which it has reported positive results from its pivotal US Phase III trial. In the study, the protocol-defined, pre-specified primary endpoint was achieved, showing a clinically and statistically significant reduction in the number of HAE attacks. Based on these positive results, the company intends to amend its BLA for Cinryze to include the prevention of HAE attacks.
Commenting on the FDA’s acceptance of the company’s BLA, Joshua Schein, CEO of Lev, said: “We are extremely pleased that the FDA has accepted our Cinryze BLA for filing and designated it for priority review. The priority designation supports our belief in the potential of Cinryze as a replacement therapy for the treatment of HAE. There currently is no acute therapy specifically approved for the treatment of HAE, and we believe that Cinryze, if approved, would represent an important option in improving the lives of patients with the disease.”