Priority status granted to ChemGenex's leukaemia treatment
Tuesday, 10 November, 2009
The U.S. Food & Drug Administration has accepted the New Drug Application (NDA) filed by ChemGenex Pharmaceuticals (ASX:CXS) for its anti-chronic myeloid leukaemia (CML) drug, Omapro.
The NDA has also been granted Priority Review, which reduces the review period compared to a regular NDA. This could mean the review could be completed in around six months.
Omapro (omacetaxine mepesuccinate), is a treatment for individuals with CML who have failed treatment with the imatinib mesylate, which is known as Glivec in Australia and Gleevec in the United States, marketed by Novartis.
Glivec is a highly effective treatment for many patients, however around 44 per cent develop a resistance to the drug, mainly due to the T315I mutation, which lends resistance to Glivec.
Clinical trials have shown that Omapro is effective in treating individuals who have developed resistance to Glivec.
Omapro has received Orphan Drug designation in the U.S. and in the European Union, and has received Fast Track status from the FDA.
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