ChemGenex reports positive pre-NDA meeting with FDA

Melbourne biotech ChemGenex has reported positve results from its pre-NDA meeting with the FDA recently regarding advancement of the company’s OMARPO (omacetaxine mepesuccinate) product for treating Chronic Myeloid Leukemia (CML).

ChemGenex said that the FDA has agreed to receive its New Drug Application (NDA) for the product based on combined data from the company’s two pivotal studies, Study 202 and Study 203, without the need for any further clinical testing.

ChemGenx is seeking FDA approval for the use of OMAPRO in the treatment of CML patients who have failed two or more tyrosine kinase inhibitors (TKIs), regardless of their mutation status, and is expected to submit its formal NDA application in the second half of next year.

“We appreciate the guidance that the FDA has given the company as it prepares this new NDA, and look forward to working with the FDA to seek approval for the use of OMAPRO to potentially treat a significantly larger patient population in the United States," said ChemGenex CEO Dr Greg Collier.