FDA accepts Lev’s complete response submission for Cinryze

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 for Cinryze. Lev submitted its complete response to FDA on April 14, 2008.

Lev is seeking marketing approval for Cinryze for both the acute and prophylactic treatment of hereditary angioedema, also known as C1 inhibitor deficiency.

Joshua Schein, CEO of Lev, said: “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.”