ChemGenex Pharmaceuticals (ChemGenex ) has submitted its New Drug Application (NDA) to the FDA for Omapro (omacetaxine mepesuccinate).
Omapro is being developed for the treatment of patients with chronic myeloid leukemia (CML) who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation.
Reportedly, Omapro has received Orphan Drug designation in the US and in the EU, and has received fast track status from the FDA.
Omapro has demonstrated clinical benefit in the pivotal Study 202, in CML patients who had failed imatinib and have the T315I mutation.
The company said that if the FDA grants priority review for Omapro the examination period is expected to be approximately six months. If approved for marketing by the FDA following priority review, the launch of Omapro would be scheduled for mid-2010.
Greg Collier, managing director and CEO at ChemGenex, said: “The submission of the NDA for Omapro is a major milestone in the development of this novel product and we are now one step closer to delivering a new treatment for patients in an area of unmet medical need. This submission is a significant achievement in our strategic goal to commercialise Omapro independently in the US oncology market.”