Erytech Pharma announced that ERY-ASP has been granted Orphan Drug Designation by the FDA for the treatment of acute myeloid leukemia (AML).

ERY-ASP is a new enzyme formulation of L-asparaginase, which exerts its therapeutic effect by entrapping and protecting the enzyme inside homologous red blood cells. By encapsulating the asparaginase enzyme in red blood cells, ERY-ASP targets leukemia cells through “starvation” while significantly reducing the side effects for patients.

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AML is the most common form of acute leukemia that affects about 34,000 new patients per year in the US and Europe, mainly adults and older patients, for which few therapeutic options are available today. The filing was based on a positive safety review of the first 30 patients treated in the ongoing Phase 2b study. If approved, ERY-ASP will be granted seven years of marketing exclusivity.

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