RxTrials Institute Drug Pipeline Alert

The FDA’s Blood Products Advisory Committee will review Lev Pharmaceuticals’ BLA for its lead product candidate, Cinryze, May 2.

Cinryze (C1 inhibitor) is for both acute and prophylactic treatment of hereditary angioedema, or C1 inhibitor deficiency, a rare, life-threatening genetic disorder.

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