FDA Accepts NDA For Omapro

The FDA has accepted ChemGenex Pharmaceuticals’ (ChemGenex) New Drug Application (NDA) for Omapro (omacetaxine mepesuccinate) 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.

The company said that the NDA has also been granted Priority Review. ChemGenex submitted the NDA on 8 September 2009.

Omapro has received Orphan Drug designation in the US and in the EU, and has received Fast Track status from the FDA. Omapro demonstrated clinical benefit in the pivotal Study 202 in CML patients who had failed imatinib and have the T315I mutation.

Greg Collier, managing director and CEO of ChemGenex, said: “We are pleased that the FDA has accepted our NDA for Omapro and granted the filing Priority Review status which underscores the critical need for a treatment option for the CML T315I+ patient population. We look forward to working closely with the agency over the next several months as they review our filing. If approved, we plan to launch Omapro in the US as the first therapy specifically indicated for CML T315I patients.”