Heart attack medicine shortage could extend over next 18 months

Pharma News: Manufacturing capacity constraints following increases in global demand had led to the shortage of a life-saving therapy used in heart attacks to offer timely myocardial revascularisation.

Boehringer Ingelheim’s (BI) Metalyse (tenecteplase) injection shortage is predicted to extend over the next 18 months.

Metalyse injection is used to dissolve blood clots (thrombolysis) in the immediate period following a heart attack. In late 2020, there were proposals to adopt Metalyse as the recommended thrombolytic agent for stroke reperfusion which would reduce its availability for patients with acute myocardial infarction for which the drug is indicated for.

There is no completed registration study of Metalyse in acute ischaemic stroke worldwide. TRACE II strives to provide evidence for a new drug application within 4.5 hours of ischaemic stroke onset through a randomised trial in China.

In consideration of the current circumstances and to maximise patient access to this essential medicine, the TGA has approved a submission from BI to extend the shelf-life of certain batches of Metalyse by 12 months, noting no change to the efficacy or safety of the therapy. 

The TGA has also approved the supply of two overseas-registered equivalent products through Pro Pharmaceuticals Group to assist the supply shortages.

In addition, the TGA is working closely with BI and clinical experts to evaluate the likely impact of interruptions to Metalyse supply. In collaboration with expert groups, clinical guidelines will be developed to assist healthcare professionals during this shortage.