EU calls for cooperation, more manufacturing to overcome GLP-1 shortage

2024-06-26

As shortages of popular GLP-1 receptor agonists persist across the EU, the European Medicines Agency (EMA) released recommendations on Wednesday calling for member states to exchange information and implement mitigation measures until there is a steady supply of the medicines.

The EMA and its Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) also called on Novo Nordisk, which markets Ozempic (semaglutide), Wegovy (semaglutide), Saxenda (liraglutide) and Victoza (liraglutide), along with US rival Eli Lilly, the developer of Mounjaro (tirzepatide) and Trulicity (dulaglutide), to increase their manufacturing capacity for the weight loss and diabetes drugs.

The EU regulator said that “a surge in demand for some of these medicines, coupled with other issues such as manufacturing capacity constraints” kicked off a drug shortage starting in 2022.

However, there’s likely not much the two pharmas can do in the short-term to boost production. The drug developers have each poured billions into building or acquiring new manufacturing sites over the last year.

Measuring mitigation

At the top of the EMA and MSSG’s recommendation list is for Eli Lilly and Novo Nordisk to work closely with member states to implement controlled distribution policies that would restrict the amount of drugs sold and ration existing supplies to ensure that patients with highest need receive treatment.

To determine which patients should be prioritised, MSSG encouraged member states to work with experts to develop guidelines, but cautioned against off-label use of GLP-1s, which could exacerbate the shortage.

Additionally, the agency asked member states to measure the effectiveness of whatever mitigation strategy they choose to implement, in order to optimise efficacy across the EU.

As a next step, MSSG will hold a workshop on July 1 with international regulators to discuss other measures to improve the supply of GLP-1 drugs in Europe.

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