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Europe’s October 2013 Products Receiving Orphan Drug Designation

October 22, 2013

The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) held a meeting October 8 – 9, 2013. The EMA COMP October 2013 Meeting on the review of applications for orphan designation is published October 17.

Some observations about the positive opinions on the recommendations for orphan designation :

•   50 % are for a cancer indication

•   A product receives orphan designation for the treatment of Mucopolysaccharidosis Type II (Hunter’s Syndrome)

•   Bayer HealthCare’s Sorafenib Tosylate receives 2 orphan designations for 2 types of thyroid cancer

•   Neuronax, a French biotechnology company developing first-in-class drugs for Spinal Cord Injuries (SCIs), receives an orphan designation for treatment of SCIs.

At this meeting, there are 12 positive opinions recommending orphan designation for the treatment of (public summaries of the opinions will be available on the EMA website following adoption of the respective decisions on orphan designation by the European Commission) :

•   Glioma (CytoVac A/S)

•   Graft-Versus-Host Disease (Gentium)

•   Mucopolysaccharidosis Type II (Hunter’s Syndrome) (Voisin Consulting)

•   Follicular Thyroid Cancer (Bayer HealthCare)

•   Papillary Thyroid Cancer (Bayer HealthCare)

•   Eosinophilic Oesophagitis (Novartis Europharm)

•   Large B-Cell Lymphoma (Janssen-Cilag International)

•   Arteriovenous Access Dysfunction (S-cubed Limited)

•   Stargardt’s Disease (Katairo GmbH)

•   Spinal Cord Injury (Neuronax SAS)

•   Hepatocellular Carcinoma (Daiichi Dankyo)

•   Ovarian Cancer (Amgen Europe).

2013 EMA COMP Calendar

  1. November 5 – 6, 2013
  2. December 10 – 11, 2013.

Please Note: “Interferon” courtesy of Linda Bartlett (Photographer) from the National Cancer Institute (NCI). [Public domain in the US].

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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