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news.For the treatment of CML patients who have failed treatment with imatinib
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EMEA has validated ChemGenex Pharmaceuticals’ (ChemGenex) Marketing Authorisation Application (MAA) for omacetaxine mepesuccinate for the treatment of chronic myeloid leukemia (CML) patients who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation.
Reportedly, the validation of the MAA indicates that ChemGenex’s application, submitted on 29 October 2009, is complete and that the review process has begun. The filing is based on data from pivotal Study 202 where omacetaxine demonstrated clinical benefit for the treatment of T315I positive CML patients.
The company said that the additional regulatory milestone follows the acceptance of a New Drug Application (NDA) by the FDA for marketing approval for omacetaxine (filed under the trade name Omapro) in the US.
Omacetaxine has received Orphan Drug designation from the EMEA and the FDA, and has received fast track status and Priority Review from the FDA. The MAA filing has been submitted in accordance with the centralised procedure and will be assessed by the EMEA.
The company has also added that an opinion by the EMEA is expected in the fourth quarter of 2010. If approved, the marketing license will be valid simultaneously in all EU Member States plus Iceland, Liechtenstein and Norway. Orphan Drug designation will give omacetaxine market exclusivity for a period of ten years.
Greg Collier, managing director and CEO of ChemGenex, said: “The submission and validation of this MAA shortly after our NDA submission and acceptance shows the commitment by ChemGenex to offer a treatment option to patients suffering from this life threatening condition.
“This milestone marks another major accomplishment for ChemGenex this year, and we remain dedicated to expanding the use of omacetaxine within CML as well as with other leukemias.”