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The COMP also said that three applications for orphan designation were withdrawn by sponsors.