The European Stroke Organisation (ESO) Executive Committee’s Thrombolysis Taskforce has provided “important updates” regarding the security of supply for Metalyse (tenecteplase) and Actilyse (alteplase) in the context of the European launch of Metalyse 25mg for acute ischaemic stroke treatment.
The European Medicines Agency (EMA) approved the use of Metalyse 25mg earlier this year, on 12 January.
A recent letter from the ESO Thrombolysis Taskforce notes that Boehringer Ingelheim—the company that markets both Metalyse and Actilyse—has adopted a stepwise approach for the launch of Metalyse 25mg.
Initially, the thrombolytic drug will be launched in 11 European countries in 2024, aligning with national reimbursement timelines and production volumes. The expected schedule for 2024 is as follows:
- February: Germany
- March: Austria
- April: Denmark, Finland, Iceland, Norway, Sweden and The Netherlands
- May: Ireland
- September: France
- October: UK
Further expansion into other European and international markets is planned from 2025 onwards, according to the taskforce.
“We would also like to make you aware that Metalyse 40mg and 50mg are specifically intended for acute myocardial infarction and should not be used for acute ischaemic stroke treatment,” the letter continues. “Use of these dosages are regarded as off-label use, and would deprive STEMI [ST segment elevation myocardial infarction] patients of essential treatment and risks destabilising the supply chain for Metalyse 25mg.”
In addition, Boehringer Ingelheim is anticipating an end of supply constraints for all Actilyse presentations in the second half of 2024—after the transfer of alteplase drug substance production to an additional Boehringer Ingelheim manufacturing site in Vienna, Austria is completed.
