Navigation Links
ATIR Classified as "Cell Based" Medicinal Product by the EMEA

A Classification for Innovative New Treatments

AMSTERDAM, December 14 /PRNewswire/ -- Kiadis Pharma announced today 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's 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's 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.

"We are very pleased having received a cell based medicinal product classification for ATIR. The regulatory guidelines that will rule ATIR are therefore clear and we have subsequently started with the application of the orphan drug designation with the EMEA which will be filed before the end of this year", said Manja Bouman, CEO Kiadis Pharma.

About ATIR

ATIR is designed to prevent life-threatening acute GvHD by eliminating the immune cells from the donor graft that otherwise attack the patient's body. Useful donor immune cells that can fight infections and remaining tumor cells are, however, spared, allowing rapid and safe donor immune reconstitution post transplantation. Acute GvHD is a major complication of allogeneic bone marrow transplantations. By preventing the occurrence of acute GvHD, ATIR enables the use of a mismatched donor and consequently addresses a significant limitation in bone marrow transplantation, the timely availability of a donor. Moreover, it could improve the general outcome of bone marrow transplants.

SOURCE Kiadis Pharma
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Non-medicinal treatment touted for pre-schoolers with ADHD
2. Nonmedicinal treatment touted for preschoolers with ADHD
3. The ScottCare Corporation Completes Acquisition of Rozinn Electronics, a Leading Manufacturer of Cardiac Diagnostic Products
4. Physician Skin Care Specialist Says Proposed New Rules for Sunscreen Products Will Better Protect the Public
5. Watson Receives First FDA Approval for Manufacturing Product at Its Goa, India Facility
6. Three Batesville Casket Company Production Facilities Honored for Manufacturing Expertise by National Organizations
7. FDA Seeks to Regulate Complementary and Alternative Medicine; Products Such as Vegetable Juice Could Be Restricted for Medical Use
8. End-to-End HR Performance Benchmarks: Metrics That Will Help Turn the HR Cost Center into a Productivity Driver
9. Boston Micromachines Multi-DM Named One of the Years Most Innovative Products
10. Drug Detection Kits Manufactured By IDenta Corp. Shown During French Television Broadcast (at TF1) - Product Aids French Police In Bust of 600 Kilograms Of Cocaine
11. Why Are Most Health & Wellness Products Doomed to Failure?
Post Your Comments:
(Date:11/30/2015)... ... November 30, 2015 , ... Using a combination of two ... American children and adults, according to a new study by researchers at the School ... in Children and Adults: Using Combinations of Blood Glucose Tests ,” published in Frontiers ...
(Date:11/30/2015)... ... ... Newly reviewed and approved “NJ Top Dentist”, Dr. Eugene Isola III, is ... in 1935. His father graduated from NYU School of Dentistry in 1965. ... their commitment and passion to the Practice of Dentistry. Continuing the family practice ...
(Date:11/30/2015)... New York, NY (PRWEB) , ... November 30, 2015 , ... ... New York Times,” will be released on December 1, 2015, to coincide with World ... book about the groundbreaking journalist who covered the AIDS epidemic as he was dying ...
(Date:11/30/2015)... ... November 30, 2015 , ... The American Society for ... honor of World AIDS Day 2015. On Nov. 30, ASCP shared its “Give a ... about World AIDS Day and the importance of getting tested for HIV. , ASCP ...
(Date:11/30/2015)... ... 30, 2015 , ... California-based i2i Systems, a pioneer defining ... Michigan-based Family Health Center (FHC) has selected i2iTracks as their population health management ... the largest Affordable Care Act grant for Federally Qualified Health Centers in the ...
Breaking Medicine News(10 mins):
(Date:11/30/2015)... Nov. 30, 2015 iCAD, Inc. (Nasdaq: ... feature its latest solutions for advanced image analysis ... cancer at the Radiological Society of North American ... from November 29 to December 4, ... including iReveal®, an automated breast density assessment solution, ...
(Date:11/30/2015)... 30, 2015  Hanger, Inc. (NYSE: HGR ) ... the terms of its previously announced consent solicitation (as ... $200,000,000 aggregate principal amount 7⅛% Senior Notes due 2018 ... consent fees payable pursuant to the Consent Solicitation, (ii) ... (iii) the expiration date of the Consent Solicitation.    ...
(Date:11/30/2015)... , November 30, 2015 Mexico Healthcare and ... Life Sciences Report 2015 . --> Pharmaboardroom releases its ... Latin America , a country of over ... a country of over 122 million people. --> It ... pharmaceuticals, or life sciences insights into the second largest pharma and ...
Breaking Medicine Technology: