So we’ve got a series of now fairly large direct head-to-head comparison trials comparing alteplase against tenecteplase, 0.25 milligrams per kilo. And essentially these were largely designed as non-inferiority trials and have largely confirmed non-inferiority of tenecteplase at that dose. If you put all the evidence together, as we’ve done recently, you have less than 1% non-inferiority margin and indeed probable slight superiority of tenecteplase compared with alteplase, at least as far as a Rankin zero to one outcome is concerned, with no issues in terms of safety...
So we’ve got a series of now fairly large direct head-to-head comparison trials comparing alteplase against tenecteplase, 0.25 milligrams per kilo. And essentially these were largely designed as non-inferiority trials and have largely confirmed non-inferiority of tenecteplase at that dose. If you put all the evidence together, as we’ve done recently, you have less than 1% non-inferiority margin and indeed probable slight superiority of tenecteplase compared with alteplase, at least as far as a Rankin zero to one outcome is concerned, with no issues in terms of safety. The ease of administration of tenecteplase is a huge advantage. Single bolus means that we have immediately removed all of the potential problems with moving patients between hospitals or within hospitals receiving incomplete doses. We’ve removed all of the concerns about significant delay between the first bolus and then maintenance infusion with alteplase. And the logistical improvements have led to very substantial reductions in door-to-needle time, door-to-puncture time for patients going for thrombectomy in other parts of the world. So I think we have felt that a global shift in tenecteplase for all use in acute stroke would be appropriate. It avoids dosing errors if you have only a single thrombolytic agent available to us and therefore the shift towards universal use of tenecteplase for thrombolysis I think is the safest and most appropriate route.
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