FDA to review Lev's Cinryze application

WASHINGTON The Food and Drug Administration’s Blood Products Advisory Committee will review Lev Pharmaceuticals’ biologics license application for Cinryze, for both acute and prophylactic treatment of hereditary angioedema on May 2.

Lev said it is preparing responses to questions the FDA posed in a Jan. 30 complete response letter.

In the letter, the FDA requests information on chemistry, manufacturing and controls, as well as additional analyses of existing efficacy data from clinical trials of Cinryze. So far, the agency has not asked for additional safety information or clinical trials.