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
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C1-esterase inhibitor joins Jerini's Firazyr and Lev's Cinryze in race to gain orphan exclusivity for acute HAE, and block other entrants
CSL Behring Submits C1-INH For Hereditary Angioedema
C1-esterase inhibitor joins Jerini's Firazyr and Lev's Cinryze in race to gain orphan exclusivity for acute HAE, and block other entrants
Lev’s Hereditary Angioedema Agent Cinryze Could Reach Market In Early 2008
The latest "ultra-orphan" compound to reach FDA is Lev Pharmaceuticals’ C1-esterase inhibitor Cinryze for the acute treatment of hereditary angioedema. Lev submitted the biologic July 31.