EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, today announced that its Biologics License Application (BLA) for ERWINAZE(R) (L-asparaginase derived from Erwinia chrysanthemi) has been accepted for filing and awarded Priority Review status by the U.S. Food and Drug Administration (FDA). Additionally, the FDA has previously awarded ERWINAZE orphan drug designation, which provides a seven-year period of market exclusivity upon approval.
EUSA Pharma completed the rolling submission of its ERWINAZE BLA on 1 November 2010, after receiving Fast Track designation from the FDA. Priority Review reduces the target regulatory assessment period to six months from the date of submission. EUSA Pharma is seeking marketing approval for ERWINAZE for use in the treatment of acute lymphoblastic leukemia in patients with hypersensitivity to E. coli-derived asparaginase. The product is currently approved in a number of countries, including Canada, the UK and several European Union member states, and is supplied in the United States under a treatment IND.
Dr Tim Corn, EUSA Pharma's Chief Medical Officer, commented, "The award of Priority Review status for ERWINAZE is another important step towards making this potentially life-saving therapy available as quickly as possible. We believe that ERWINAZE has the potential to enhance the treatment of acute lymphoblastic leukemia greatly, and hope that the ongoing Priority Review will shorten the period before U.S. oncologists can offer this key therapeutic alternative to their patients."