April 15, 2008--Lev Pharmaceuticals, Inc. today announced that it has formally submitted its complete response to the U.S. Food and Drug Administration's (FDA) complete response (or "approvable") letter for the Company's lead product candidate, Cinryze(TM) (C1 inhibitor). Lev is seeking marketing approval for Cinryze(TM) for both the acute and prophylactic treatment of hereditary angioedema (HAE), also known as C1 inhibitor deficiency.
A complete response letter is issued by FDA to request additional information in connection with its review. In its letter, FDA requested information with respect to chemistry, manufacturing, and controls (CMC), as well as additional analyses of existing efficacy data from the Cinryze(TM) trials. No additional safety information and no additional clinical trials have been requested to date.
In addition, Lev is scheduled to present to the Blood Products Advisory Committee (BPAC) on May 2, 2008. Advisory committees provide FDA with independent advice from outside experts. The BPAC meeting represents the next stage in the regulatory process for Lev as the Company continues to work with FDA toward obtaining market approval for Cinryze(TM).
No comments:
Post a Comment