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news.Gendux and Introgen Therapeutics have reached an agreement with the European Medicines Agency Committee to file for marketing approval for Advexin p53 therapy.
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The application will be for the use of Advexin p53 therapy for the treatment of Li-Fraumeni Syndrome (LFS). LFS is a genetic disorder characterized by inherited mutations in the p53 tumor suppressor gene.
Gendux also announced that Advexin has been confirmed by the European Commission as an orphan medicinal product. In a related European regulatory action, last month Advexin was recommended for orphan drug status for the treatment of LFS. Orphan drug registration in Europe confers a number of regulatory and commercial benefits for products.
“This special provision in the European rules allows us to seek an expedited registration of Advexin in Europe while at the same time advancing our head and neck registrations both in Europe as well as the US,” said Dr Max Talbott, senior vice president of Worldwide Commercial Development and Regulatory Affairs at both Introgen and Gendux.
Over the coming months Introgen and Gendux plan to complete the filing of Advexin applications for the European approval of LFS treatment and the European and US approval of Advexin p53 for head and neck cancer.