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Europe’s April 2015 Products Recommended For Orphan Drug Designation

April 23, 2015

The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) held a meeting April 14 – 16, 2015.

At this meeting, there are 13 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 April 2015 ODDs Recommended

Product Name Sponsor Company Indication
{2-amino-8-[4-(pyrrolidinylcarbonyl)phenyl]-(3H-benzo[f]azepin-4-yl)}-N,N-dipropylcarboxamide Right Track Regulatory Limited Ovarian Cancer
AASSGVSTPGSAGHDIITEQPRS (P42) Centre National de la Recherche Scientifique (CNRS) Huntington’s Disease
Adeno-associated viral vector serotype 9 containing the human HGSNAT gene Cochamo Systems Ltd Mucopolysaccharidosis IIIC (Sanfilippo C Syndrome)
Fusion proteins composed by a genetically modified cholera toxin subunit A1, peptides from the acetylcholine receptor alpha chain & a dimer of the D fragment from Staphylococcus aureus protein A Toleranzia AB Myasthenia Gravis
Reduced oxydised N-acetyl heparin Sigma-Tau Pharma Ltd Plasma Cell Myeloma
Triamcinolone acetonide S-cubed Limited Non-Infectious uveitis
2-(7-ethoxy-4-(3-fluorophenyl)-1-oxophthalazin-2(1H)-yl)-N-methyl-N-(2-methylbenzo[d]oxazol-6-yl)acetamide Clinical Network Services (UK) Ltd Cystic Fibrosis
5,7-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride Prana Biotechnology UK Limited Huntington’s Disease
Adult human bone-marrow-derived, ex-vivo-expanded, pooled allogeneic mesenchymal stromal cells Regulatory Resources Group Ltd Thromboangiitis obliterans (Buerger’s Disease)
Allopurinol sodium ACE Pharmaceuticals BV Perinatal asphyxia
Humanised anti-CD37 monoclonal antibody conjugated to maytansinoid DM1 ImmunoGen Europe Limited Diffuse large B-cell lymphoma
Trehalose Dr. Ulrich Granzer Oculopharyngeal Muscular Dystrophy
Triheptanoin Pharma Gateway AB Glucose transporter type-1 deficiency syndrome

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

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