FDA approved EUSA Pharma’s orphan drug Erwinaze™ (asparaginase Erwinia chrysanthemi) for the treatment of acute lymphoblastic leukemia (ALL) in patients with hypersensitivity to E. coli-derived asparaginase. The firm says the product is the only approved treatment option for patients with hypersensitivity to standard-of-care therapy using E.coli-derived pegaspargase.
Current treatment protocols for ALL typically involve asparaginase, but an estimated 15–20% of ALL patients develop hypersensitivity to E. coli-derived asparaginase, which equates to about 450–600 children in the U.S. every year, EUSA claims. Approval of Erwinaze in the U.S. was based on data from clinical studies in 630 ALL patients, including a pivotal study in 58 patients in which 100% of evaluable patients achieved the asparaginase activity primary endpoint.
Founded in 2006, specialty pharmaceutical company EUSA is focused on in-licensing, developing, and marketing late-stage oncology, oncology supportive care, and critical care products. The firm has nine products on the market, including Erwinase and Kidrolase® for treatment of acute lymphoblastic leukemia, Caphosol® for the treatment of oral mucositis, an antibiotic surgical implant Collatamp®, ProstaScint® for imaging the extent and spread of prostate cancer, and Quadramet® for the treatment of pain in bone metastatic cancer patients. EUSA also has several products in late-stage development, including the monoclonal antibody Leukotac®, which is undergoing Phase III trials for the treatment of steroid resistant acute graft versus host disease.