EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ERWINASE(R) (L-asparaginase derived from Erwinia chrysanthemi) for use in the treatment of acute lymphoblastic leukemia in patients with hypersensitivity to E. coli-derived asparaginase. ERWINASE 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.
EUSA Pharma submitted its ERWINASE BLA on a rolling basis, following receipt of Fast Track designation from the FDA. The completed BLA submission requests Priority Review status, which can reduce the regulatory assessment period to six months for major treatment advances. Additionally, the FDA has awarded ERWINASE orphan drug designation, which provides a seven-year period of market exclusivity upon approval.
Dr Tim Corn, EUSA Pharma's Chief Medical Officer, commented, "The submission of our ERWINASE BLA is a major step towards our goal of making this important therapy available as rapidly as possible. Many children with acute lymphoblastic leukemia develop allergy to current asparaginase products, and ERWINASE provides a key therapeutic alternative for this gravely ill group in several countries around the world. By applying for Priority Review status, we hope to shorten the period before EUSA can launch ERWINASE in the U.S., and reduce the time before physicians can provide this potentially life-saving drug to those who may benefit from it."
"Completing the BLA filing for ERWINASE marks a major strategic milestone for EUSA," said Bryan Morton, EUSA Pharma's President and Chief Executive Officer. "Based on new study results and existing clinical experience, we believe ERWINASE has the potential to enhance the treatment of acute lymphoblastic leukemia significantly, both in the U.S. and further afield. In the coming months, EUSA plans to achieve pan-European authorization for ERWINASE, and our partners are pursuing regulatory approval in Japan and elsewhere. As a result, ERWINASE has the opportunity to become EUSA's second global product, marking the company's rapid transformation into a leading player in the specialty oncology field."
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