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NEW ANA testing does not diagnose disorder in 40% of scleroderma patients

November 07, 2017

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."

SOURCE EUSA Pharma