COMP adopts positive opinion on 10 new drugs

The 80th meeting of the European Medicines Agency's (EMEA) Committee for Orphan Medicinal Products, held late last month, saw the adoption of 10 positive opinions on Orphan Drugs under its consideration.

Products recommended for orphan approval include: Cephalon's arsenic trioxide for acute myeloid leukemia; Bayer's ciprofloxacin as an inhalation therapy for cystic fibrosis; the antimalarial dihydroartemisinin piperaquine developed by Sigma Tau Industrie Farmaceutiche Riunite SpA; Kedrion SpA's human plasminogen for the treatment of ligneous conjunctivitis; GlaxoSmithKline's eltrombopag olamine for idiopathic thrombocytopenic purpura; the Weinberg Group's L-threo-3,4-dihydroxyphenylserine for indications including orthostratic hypertension in patients with multiple system atrophy and in those with pure autonomic failure; Novartis Europharm's panobinostat lactate for cutaneous T-cell lymphoma; the cardiogenic shock drug pyridoxalated hemoglobin polyoxyethylene developed by Curacyte AG; and SuppreMol GmBH's soluble human Fc-gamma IIb receptor for idiopathic thrombocytopenic purpura.