FDA backs EUSA Pharma's orphan leukemia drug Erwinaze

UK and USA-based specialty drug firm EUSA Pharma says that the US Food and Drug Administration 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.

Erwinaze will be available to patients throughout the USA immediately, says EUSA, which will offer a patient assistance program to help expand access to the new treatment for patients who lack health insurance or meet certain other criteria.

The drug, which was originally discovered by the UK Health Protection Agency, is currently approved for the treatment of acute lymphoblastic leukemia in patients with hypersensitivity to E. coli-derived asparaginase in a number of countries, including Canada, the UK and several other European Union member states.