US FDA grants orphan status for omacetaxine

The USA's ChemGenex Pharmaceuticals says that the Food and Drug Administration has granted Orphan Drug designation to omacetaxine for  the treatment of myelodysplastic syndromes.

MDS describes a group of bone marrow disorders that are characterized by  a defect in stem cells. It is most common in elderly patients as they  are more prone to bone marrow damage but it can occur in any age group.  Approximately 15,000 people per year in the USA are diagnosed with MDS,  making its overall annual incidence five cases per hundred thousand  people.

Hagop Kantarjian, chairman of the Department of Leukemia at MD Anderson  Cancer Center in Houston, Texas, said: "MDS is a very important blood  disorder with significant unmet clinical needs in patients who fail  approved therapies. Published data has demonstrated the clinical  activity of omacetaxine in this patient population and we look forward  to future possible clinical trials to consolidate our understanding of  this product in the treatment of MDS."