Action Letter For Lev’s Cinryze Opens Window For Jerini To Hit Market First
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Lev Pharmaceuticals received a "complete response" letter from FDA on its BLA for the C1-esterase inhibitor Cinryze for hereditary angioedema, giving German drug maker Jerini an opportunity to be first to market with a treatment for the orphan disease