ATIR classified as "cell based" medicinal product by the EMEA
Kiadis Pharma announced that its lead product ATIR has received approval for regulatory classification as a "cell based" medicinal product by the Innovation Task Force (ITF), a division of the European Medicines Agency (EMEA). Based upon this regulatory classification ATIR is eligible for EMEA procedures. As a next step Kiadis Pharma will file for Orphan Drug Designation with the EMEA to obtain additional product protection upon marketing approval. In November this year ATIR has been granted orphan drug designation by the US food and Drug Administration (FDA).
ATIR is under development to prevent acute Graft versus Host Disease (GvHD) allowing the use of a mismatched donor for bone marrow transplantations. It is a personalized cell-based treatment prepared according to a proprietary protocol using both a novel small molecule substance and a proprietary medical device. With the official classification of ATIR as a cell based medicinal product by the EMEA, it is now categorized as an Advanced Therapy, and considered to be a highly innovative treatment. The benefits are a centralized marketing authorization procedure, which harmonizes and facilitates access to the European market. In addition, it provides access to an expert Committee for Advanced Therapies within the EMEA, to address scientific, legal and regulatory issues during product development.
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