first approval for tirilazad

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22 First approval for tirilazad Tirilazad ['Freedox'; Upjohn] has been approved in Austria for the treatment of subarach- noid haemorrhage in men (Scrip 2005: 21. 7 Mar 1995]. This is the first approval worldwide for the lazaroid drug. 1be decision of the Austrian regulatory authorities was based on the findings of a European and Australasian study in which use of tirilazad was associated with a significant decrease in mortality among men with subarachnoid haemorrhage. TIrilazad is the first of a new class of drugs, lipid perolticiation inhibitors, developed for the prevention of secondary tissue damage following eNS injury. Applications for approval of the agent for this indication have been filed in 31 countries. Tirilazad is currently being investigated in clinical trials for the treatment of head and spinal cord injuries, and ischaemic stroke. However, Upjohn recently suspended a large North American placebo-controlled tria) of the drug in severe and moderate head injury because of an unexpectedly high mortality rate among tirilazad recipients [see Inphanna 969: 24, 14 Jan 1995; 800328693). 11 "'-f '1I5 INPHARMA·

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Page 1: First approval for tirilazad

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First approval for tirilazad

Tirilazad [' Freedox'; Upjohn] has been approved in Austria for the treatment of subarach­noid haemorrhage in men (Scrip 2005: 21. 7 Mar 1995]. This is the first approval worldwide for the lazaroid drug.

1be decision of the Austrian regulatory authorities was based on the findings of a European and Australasian study in which use of tirilazad was associated with a significant decrease in mortality among men with subarachnoid haemorrhage.

TIrilazad is the first of a new class of drugs, lipid perolticiation inhibitors, developed for the prevention of secondary tissue damage following eNS injury. Applications for approval of the agent for this indication have been filed in 31 countries.

Tirilazad is currently being investigated in clinical trials for the treatment of head and spinal cord injuries, and ischaemic stroke. However, Upjohn recently suspended a large North American placebo-controlled tria) of the drug in severe and moderate head injury because of an unexpectedly high mortality rate among tirilazad recipients [see Inphanna 969: 24, 14 Jan 1995; 800328693).

11 "'-f '1I5 INPHARMA·