Navigation Links
ATIR Classified as "Cell Based" Medicinal Product by the EMEA
Date:12/14/2007

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:
*Name:
*Comment:
*Email:
(Date:4/28/2017)... , ... April 28, 2017 , ... ... announce the integration of Microsoft(R) Word(TM) Online(TM), which enables sleep physicians to create ... it streamlines the reporting process and provides a familiar interface that does not ...
(Date:4/28/2017)... ... ... sleep affects much more than energy – it also has mental and physical benefits. According ... reaction time, which can increase the risk of having a car accident. , This ... NSF to help you sleep better and feel better:, , Turn ...
(Date:4/28/2017)... ... April 28, 2017 , ... Ushio America proudly ... offer an instant energy-saving solution for F32T8 fluorescent lamps on most instant-start and ... These 50,000 hour rated lamps utilize the existing electronic ballast, saving labor and ...
(Date:4/28/2017)... ... April 28, 2017 , ... ... exposed to more adverse experiences than children in the general population. That’s because ... abuse, neglect or other family challenges. While no fault of their own, youth ...
(Date:4/28/2017)... ... April 28, 2017 , ... Early detection ... improve drug safety and minimize the cost of development. In this webinar, sponsored ... using cell lines and for cardiac toxicity using induced pluripotent stem cells (iPSCs). ...
Breaking Medicine News(10 mins):
(Date:4/20/2017)... 20, 2017  RXi Pharmaceuticals Corporation (NASDAQ: RXII), ... address significant unmet medical needs, today announced that ... consumer product development program, based on its proprietary ... Investigative Dermatology (SID) 76 th Annual Meeting.  ... the sciences relevant to skin health and disease ...
(Date:4/20/2017)... 20, 2017   ZappRx, Inc ., a digital health ... process, today announced it closed $25 million in Series B ... firm based in Seattle that is ... . The Series B round included participation from SR ... and GV (formerly Google Ventures). As part of ...
(Date:4/20/2017)... -- Eyevensys, a private biotechnology company developing ... technology that enables the safe, local, sustained production of ... range of ophthalmic diseases, announces it has received approval ... (MHRA) to advance its technology into clinical development. ... The EyeCET platform ...
Breaking Medicine Technology: