EUSA Pharma announced that the FDA has approved its orphan drug Erwinaze (asparaginase Erwinia chrysanthemi) for the treatment of acute lymphoblastic leukemia (ALL) in patients with hypersensitivity to E. coli-derived asparaginase. This approval is based on the results of clinical studies in 630 patients with ALL. In the pivotal efficacy study conducted in 58 patients, 100% of evaluable patients achieved the asparaginase activity primary endpoint.

Erwinaze is an asparaginase enzyme that depletes the level of asparagine in the bloodstream. Asparagine is essential for cell growth, and its removal from the blood inhibits the growth of cells associated with acute lymphoblastic leukemia. Erwinaze is indicated as an integral part of a multi-agent regimen for the treatment of patients with ALL who develop hypersensitivity to current products derived from E. coli.

Erwinaze is available as 10,000IU asparaginase Erwinia chrysanthemi per vial.

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