Two More Launches For Upjohn's Freedox

Upjohn has received approval in two further countries, Denmark and Sweden, for its Freedox IV Solution (tirilazad mesylate injection) as a treatment for aneurysmal subarrachnoid hemorrhage. The lazaroid compound was first approved in Austria earlier this year (Marketletter March 13).

Freedox is thought to achieve its neuroprotective effects via a number of different mechanisms, including inhibition of free radical generation, lipid peroxidation, stabilization of cell membranes and preservation of levels of endogenous antioxidants. The two countries' regulation authorities approval for Freedox was based on the results of a European/ Australasian trial which showed a significant reduction in mortality in men.

Results of the study revealed that a group of patients who received Freedox at a dose of 6mg/kg a day had a 43% decrease in mortality compared to a placebo-treated group. The drug also reduced the need for expensive hypertensive rescue therapy by 44% in these patients, according to Upjohn. The company is pursuing worldwide registration of Freedox in aneurysmal SAH, and other applications have been made in 31 countries. However, last September a US Food and Drug Administration advisory panel postponed giving a recommendation on whether Freedox should be granted approval in the USA for the treatment of severe aneurysmal SAH, saying that it wanted more information on the effectiveness of the drug.