NETHERLANDS – The European Medicines Agency (EMA) has put EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

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.

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.

It also plans to 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 receive any alternatives.

In a recent development, Boehringer Ingelheim received landmark approval from the FDA for Spevigo, an interleukin-36 receptor inhibitor for the treatment of generalized pustular psoriasis (GPP).

GPP is a rare and life-threatening skin condition that causes eruptions of painful blisters. These GPP flares are so disruptive to the system that they can trigger heart failure, renal failure, or sepsis. 

The IL-36 receptor inhibitor is also under review in Europe, and a decision is expected before the end of this year. It is the first dermatology approval for the German firm.

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