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Europe’s March 2015 Products Recommended For Orphan Drug Designation

March 30, 2015

The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) held a meeting March 17 – 19, 2015.

At this meeting, there are 15 positive opinions recommending the following medicines for designation as orphan medicinal products. COMP’s opinions are forwarded to the European Commission (EC). The EC will then decide whether to grant an orphan designation for the medicines in question. Public summaries of the opinions will be available on the EMA website following adoption of the respective decisions on orphan designation by the EC.

EMA COMP March 2015 ODDs Recommended

Product Name Sponsor Company Indication
1-(4-(N-glycylamido)phenyl)-3-trifluoromethyl-5-(phenanthren-2-yl)-pyrazole-hydrochloride Arno Therapeutics UK, Limited Cryptococcosis
1-(4-(N-glycylamido)phenyl)-3-trifluoromethyl-5-(phenanthren-2-yl)-pyrazole-hydrochloride Arno Therapeutics UK, Limited Tularaemia
Ecothiophate Iodide JJG Consultancy Ltd Stargardt’s Disease
Fluciclovine (18F) Blue Earth Diagnostics Ltd Diagnosis of Glioma
Human reovirus type 3 Dearing strain Oncolytics Biotech (UK) Limited Pancreatic Cancer
Lenalidomide Celgene Europe Limited Marginal Zone Lymphoma
Recombinant monoclonal IgG1 antibody against T-cell immune response cDNA 7 Nekonal S.a.r.l. Prevention of graft rejection following solid organ transplantation
Rimeporide EUDRAC Limited Duchenne Muscular Dystrophy
Rintatolimod NV Hemipsherx BioPharma Europe Ebola Virus Disease
Adeno-associated viral vector serotype 5 containing the human CHM gene HORAMA SAS Choroideremia
Nitric Oxide Biological Consulting Europe Ltd Cystic Fibrosis
Phenol, 4-[2-(aminomethyl)-4-thiazolyl]-2,6-bis(1,1-dimethylethyl) monohydrochloride Ipsen Pharma Huntington;s Disease
Recombinant human mesencephalic astrocyte-derived neurotrophic factor Clinipace GmbH Retinitis Pigmentosa
Sodium 2-hydroxylinoleate Ability Pharmaceuticals SL Neuroblastoma
Xenon Neuroprotexeon Ltd Perinatal Asphyxia

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Please Note: “Erlenmeyer Flasks” From Argonne US National Lab  [Public domain in the US] | Wikimedia Commons.

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