Eusa Pharma ‘remains optimistic regarding Erwinaze

Eusa Pharma has revealed that it has high hopes that its Erwinaze product will be approved by the Food and Drug Administration (FDA).

The medicine is currently approved for the treatment of acute lymphoblastic leukemia in patients with hypersensitivity to E. coli-derived asparaginase in Canada, the UK and several other EU states.

Eusa Pharma submitted a biologics licence application in the US and the FDA is continuing to review the situation, with the product already having orphan drug designation in the country, where it is supplied under a treatment IND.

Dr Tim Corn, the company's chief medical officer, commented: "Given the additional information requested previously by the agency, we respect the need for further time to complete the review. We remain optimistic."

In May, the FDA extended its review by 90 days in order to consider extra material and had intended to arrive at a decision by August 2nd, a deadline which has now passed.