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Europe’s January 2015 Products Recommended For Orphan Drug Designation

January 15, 2015

The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) held a meeting January 7 – 9, 2015.

At this meeting, there are 19 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 January 2015 ODDs Recommended

Product Name Sponsor Company Indication

3-[2-(4-carbamimidoyl-phenylcarbamoyl)-5-methoxy-4-vinyl-phenyl]-6-(cyclopropylmethylcarbamoyl)-pyridine-2-carboxylic acid

BioCryst UK Ltd Hereditary angioedema
Chimeric group B adenovirus (11p/3) with deletions in the E3 and E4 regions PsiOxus Therapeutics Ltd Ovarian Cancer
Fibrinogen-coated albumin spheres  Fibreu Limited Ebola virus disease
Nitroglycerin Covis Pharma S.à.r.l. Systemic sclerosis
Sevuparin sodium Dilaforette AB Sickle cell disease

2′-O-methyl phosphorothioate RNA oligonucleotide, 5′-

m5CUGm5CUGm5CUGm5CUGm5CUGm5CUGm5CUG-3′

Prosensa Therapeutics B.V. Huntington’s Disease

505 amino acid protein, corresponding to amino acids 2-506 of the wild type human histidyl-tRNA synthetase

Voisin Consulting S.A.R.L. facioscapulohumeral muscular dystrophy
5-hydroxymethyl-2-furfural Baxter Innovations GmbH Sickle Cell Disease

Allogeneic CD4+ and CD8+ T lymphocytes ex vivo incubated with synthetic peptides of the viral antigens of cytomegalovirus, adenovirus and Epstein-Barr virus

Miltenyi Biotec GmbH

Cytomegalovirus infection following haematopoietic stem cell transplantation

Allogeneic CD4+ and CD8+ T lymphocytes ex vivo incubated with synthetic peptides of the viral antigens of cytomegalovirus, adenovirus and Epstein-Barr virus

Miltenyi Biotec GmbH

Epstein-Barr virus infection following haematopoietic stem cell transplantation

Allogeneic CD4+ and CD8+ T lymphocytes ex vivo incubated with synthetic peptides of the viral antigens of cytomegalovirus, adenovirus and Epstein-Barr virus

Miltenyi Biotec GmbH

Adenovirus infection following haematopoietic stem cell transplantation

Alvocidib Theorem Clinical Research GmbH Acute myeloid leukaemia
Lactobacillus reuteri Infant Bacterial Therapeutics Prevention of necrotising enterocolitis
Mazindol HAC Pharma Narcolepsy
Myriocin Nanovector s.r.l. Retinitis pigmentosa

N-(3-(4-(3-(diisobutylamino)propyl)piperazin-1-yl)propyl)-1H-benzo[d]imidazol-2-amine disulphate salt

Progressive supranuclear palsy AlzProtect sas
Olaratumab Eli Lilly Nederland B.V. Soft tissue sarcoma
Recombinant human glutamate oxaloacetate transaminase 1 Impasara Ltd Glioma
Ulocuplumab Bristol-Myers Squibb Pharma EEIG acute myeloid leukemia

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

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