EMA warns of shortages of two Boehringer heart drugs due to a spike in demand
The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.
On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.
The EMA warnings said that a rise in demand for the drugs is leading to an overall shortage that is expected to last until 2024. Both drugs are manufactured at Boehringer’s facility in Biberach, Germany.
A Boehringer Ingelheim spokesperson told Endpoints News in an email that the specific causes of the shortage include an aging population being more susceptible to heart attacks and strokes, as well as recommendations for the drugs being expanded.
In 2022, healthcare professionals are treating ever-increasing numbers of patients requiring thrombolytic treatments such as Actilyse and Metalyse. In anticipation of rising demand, Boehringer Ingelheim has more than doubled its production capacity at its facility in Biberach, Germany, over the last 10 years.
“With rising global demand for thrombolytic treatments despite all efforts we have reached a point where the production of these medicines is no longer keeping up with demand,” the spokesperson said.
With Boehringer Ingelheim at maximum production capacity in Biberach, the EMA said in its warning that, within the next three years, a new manufacturing site will be established to increase capacity. The company spokesperson told Endpoints that it is planning to transfer all Actilyse drug manufacturing to a new site in Vienna, allowing space to free up in Biberach for Metalyse production.
In the meantime, Boehringer Ingelheim is taking several measures to extend the supply. It is planning to submit a variation application globally to extend the shelf life of Metalyse from 24 to 36 months to avoid the return of unused vials after the expiration date and increase the volume of Actilyse’s 20mg doses to discourage the use of the 50mg version and reduce product wastage.
Boehringer Ingelheim is also developing a manufacturing process for Actilyse that will give it a higher yield, which was approved by EU health authorities last month.
For now, the EMA is advising health providers to extend supplies for as long as possible, and any information on alternatives should be referred to national agencies. Additionally, patients should reach out to health providers for more information or to receive any alternatives.