The eighty-first meeting of the Committee for Orphan Medicinal Products (COMP) took place on 24-25 July 2007. The Committee thanked warmly Dr Julia Dunne (CHMP representative), who will leave the COMP, for her successful contribution to the work of the Committee.
COMP Opinions for Orphan Medicinal Product Designation
The Committee adopted 13 positive opinions on orphan medicinal product designation during this meeting:
- 4-Amino-1-[5-O-[(2R,4S)-2-oxido-4-(4-pyridinyl)-1,3,2-dioxaphosphorinan-2-yl]-β-D-arabinofuranosyl]-2(1H)-pyrimidinone from Interface International Consultancy Ltd, for treatment of hepatocellular carcinoma (review time: day 41)
- 5'-O-(trans-9"-octadecenoyl)-1-ß-D-arabinofuranosyl cytosine from Clavis Pharma ASA, for treatment of acute myeloid leukaemia (review time: day 41)
* R-salbutamol sulphate from Astion Pharma A/S, for treatment of cutaneous forms of lupus erythematosus (review time: day 90)
- Cyclo {{(E,Z)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)nona-6,8-dienoyl}-L-2-aminobutyryl-N-methyl-glycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl} from Lux Biosciences GmbH, for treatment of chronic non-infectious uveitis (review time: day 90)
- Alpha-1 proteinase inhibitor (inhalation use) from CSL Behring GmbH, for treatment of cystic fibrosis, (review time: day 41)
- Alginate oligosaccharide (G-block) fragment from AlgiPharma AS, for treatment of cystic fibrosis (review time: day 90)
- Human autologous bone-forming cells derived from bone marrow stem cells from Bone Therapeutics SA, for treatment of aseptic non-traumatic osteonecrosis (review time: day 41)
- Human coagulation factor X from Bio Products Laboratory, for treatment of hereditary factor X deficiency, (review time: day 41)
- Human heterologous liver cells (for infusion) from Cytonet GmbH & Co. KG, for treatment of ornithine-transcarbamylase deficiency (review time: day 41)
- N-(2-amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide from Pharmion Ltd, for treatment of Hodgkin's lymphoma (review time: day 41)
- N-adamantanyl-N'-Geranyl-ethylenediamine from RLM Consulting, for treatment of tuberculosis (review time: day 41)
- Naptumomab estafenatox from Active Biotech Research AB, for treatment of renal cell carcinoma (review time: day 41)
- Sulfonated monophosphorylated mannose oligosaccharide from Constella Group Ltd, for treatment of hepatocellullar carcinoma (review time: day 41)
Withdrawals of Orphan Medicinal Product Applications
The COMP noted that three applications for orphan medicinal product designation were withdrawn during evaluation.
emea.europa.eu