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Europe’s December 2013 Products Receiving Orphan Drug Designation

January 14, 2014

The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) held a meeting December 10 – 11, 2013. The EMA COMP December 2013 Meeting Report on the review of applications for orphan designation is published January 13.

At this meeting, there are 13 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) :

•   Acute Myeloid Leukemia (Voisin Consulting S.A.R.L.)

•   Acute Lymphoblastic Leukemia (Voisin Consulting S.A.R.L.)

•   Adenovirus infection in allogeneic hematopoietic stem cell transplant recipients (Cell Medica Ltd.)

•   Epidermolysis Bullosa (EB) (ORS Oxford Ltd)

•   Graft-versus-host disease (ReGenesys BVBA)

•   Malignant mesothelioma (Amphera BV)

•   Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (Hybrigenics SA)

•   Hepatitis delta virus infection (Eiger Biopharmaceuticals Europe Limited)

•   Primary sclerosing cholangitis (Intercept Italia S.R.L.)

•   Aneurysmal subarachnoid haemorrhage (Hope Pharmaceuticals Ltd)

•   Dystrophic Myotonia (Valentia BioPharma S.L.)

•   Malignant mesothelioma (Eisai Europe Limited)

•   Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (Celgene Europe Limited).

Please Note: “Cambio de color a diferente pHs” by Rubashkyn (Own work) [CC-BY-SA-3.0] | Wikimedia Commons.

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