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EU’s COMP announces positive opinion on nine orphan drugs

The EU's Committee for Orphan Medicinal Products or COMP has adopted positive opinions on nine orphan drug designations at its meeting on February 5, 2008.

The drugs that received positive opinions from the COMP were: Centocor’s (Johnson & Johnson) allogeneic human umbilical cord tissue-derived cells for the treatment of retinitis pigmentosa; JJGConsultancy’s ammonium tetrathiomolybdate for the treatment of Wilson’s disease; Pharmion’s amrubicin hydrochloride for the treatment of small cell lung cancer; Ascorbic acid, from Murigenetics, for treatment of Charcot-Marie-Tooth disease type 1A; Autologous urothelial and smooth muscle cells, from Choice Pharma, for the treatment of spina bifida; Chiltern International’s chimearic antibody to mesothelin for the treatment of pancreatic cancer; Sygnis Bioscience’s filgrastim for the treatment of amyotrophic lateral sclerosis; Humanised monoclonal antibody to the folate receptor alpha, from Chiltern International, for the treatment of ovarian cancer; and Recombinant human monoclonal antibody against transforming growth factor beta-1, 2 and 3, from Genzyme Europe, for the treatment of idiopathic pulmonary fibrosis.

The COMP also said that three applications for orphan designation were withdrawn by sponsors.