May 6, 2008 - Lev Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Lev's complete response submission for Cinryze(TM) (C1 inhibitor), the Company's lead product candidate. 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.
In addition, the FDA has designated Lev's complete response as a Class 2 resubmission, establishing an October 14, 2008 target action date to complete its review of the biologics license application (BLA) for Cinryze(TM). Lev submitted its complete response to FDA on April 14, 2008.
"As expected, the FDA has determined our response to be a Class 2 resubmission, and we look forward to further advancing our application through the FDA's review process," said Joshua Schein, chief executive officer of Lev.
The FDA issued a complete response letter (or "approvable" letter) on January 30, 2008 requesting 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.
On May 2, 2008, the Blood Products Advisory Committee (BPAC) to the FDA voted unanimously that there is sufficient evidence of the safety and efficacy for the approval of Cinryze(TM) (C1 inhibitor) for the prophylactic treatment of HAE. The data from Lev's acute treatment trial was not presented before the BPAC and is currently under active review at FDA.
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