METALYSE (ténectéplase) - Ischaemic stroke

The clinical benefit of METALYSE 5,000 IU (25 mg tenecteplase) powder for solution for injection is substantial in the MA indication.

Considering:

• the available efficacy results, based primarily on the pivotal phase 3 AcT study, suggesting the non-inferiority of tenecteplase compared to alteplase in terms of complete functional recovery after 3 months (clinically relevant endpoint for patients) in patients with disabling acute ischaemic stroke treated within 4.5 hours following the onset of symptoms,
• the non-optimal quality of evidence of non-inferiority in the AcT study, due to an inappropriately predefined non-inferiority margin,
• safety data from the AcT and EXTEND-IA studies, suggesting a bleeding profile similar to that of alteplase, with no observed benefit on symptomatic intracranial haemorrhage in particular,
• the lack of evidence of an improvementin the care and/or life pathway of patients associated with the simplified administration methods compared to alteplase, with, in particular, comparable median times to treatment for alteplase and tenecteplase in the pivotal AcT study (including the time between arrival in hospital and performance of angiography, and the time between
  angiography and arterial puncture in patients undergoing thrombectomy),
• the absence of long-term efficacy data,

the Committee deems that METALYSE 5,000 IU (tenecteplase) powder for solution for injection provides no clinical added value (CAV V) compared to alteplase (ACTILYSE) in the treatment of adults with acute ischaemic stroke (AIS) within 4.5 hours from last known well and after exclusion of intracranial haemorrhage.