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www.fdanews.com/articles/81720-arginox-receives-orphan-drug-designation-for-cs-medication

ARGINOX RECEIVES ORPHAN-DRUG DESIGNATION FOR CS MEDICATION

October 17, 2005

Arginox Pharmaceuticals has announced that the Committee for Orphan Medical Products, a division of the European Medicines Agency, has recommended orphan-drug designation in the European Union to tilarginine acetate injection (TAI) for the treatment of cardiogenic shock (CS). This favorable opinion requires final ratification by the European Commission. TAI has already been granted orphan drug designation from the FDA.

CS is one of the most serious complications of a heart attack. Despite major advances in acute cardiac care that have led to dramatic improvements in heart attack survival overall, a similar benefit has not been realized for CS. Recent research and data from large-scale heart attack registries indicate that mortality from CS remains 40 percent to 50 percent under the best treatment conditions and is frequently much higher. The condition is characterized by circulatory collapse, leading to organ failure and death. Approximately 9 percent of myocardial infarction patients experience CS.