MELBOURNE, Australia An Australian drug maker has submitted its approval application to the Food and Drug Administration for a new drug to treat leukemia.
ChemGenex announced the submission of the application for Omapro (omacetaxine mepesuccinate), designed to treat chronic myeloid leukemia in patients for whom Novartis’ Gleevec (imatinib), a first-line treatment for CML, has not worked and who have a gene mutation called T315I.
Omapro, the first drug of its class, has received orphan drug designation from the FDA. The FDA grants the designation to investigational drugs that treat rare diseases or diseases for which no adequate treatments exist, giving them certain advantages in the drug approval process such as fast-track review and longer market exclusivity periods.
“If approved, Omapro would be the first treatment specifically indicated for CML T315I patients, many of whom have no therapeutic options,” ChemGenex SVP and chief medical officer Adam Craig said in a statement.