Company filed a complete response to FDA’s approvable letter and inked supply agreements with Plasma Centers of America.
Lev Pharmaceuticals is making strides to get its hereditary angioedema (HAE) therapy, Cinryze, approved after delays at the FDA and to set itself up for a potential launch. The firm Lev submitted its complete response to the agency’s letter received in February.
The company also signed a strategic supply agreement with Plasma Centers of America to construct and purchase a maximum of three plasma collection centers in the U.S. Lev will also have exclusive rights to make periodic purchases of U.S.-source plasma from each new collection center through December 31, 2010.
“This agreement is aimed at providing Lev with an ancillary source of U.S. plasma supply in anticipation of launch of our lead product candidate, Cinryze™ for the treatment of hereditary angioedema, upon FDA approval,” notes Judson Cooper, chairman of Lev.
Lev is seeking marketing approval for Cinryze in the acute and prophylactic setting. In today’s submission, Lev addressed FDA concerns regarding chemistry, manufacturing, and controls (CMC) as well as provides additional analyses of existing efficacy data from the Cinryze trials.