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The European Medicines Agency (EMA) has recommended that member countries develop guidelines to prioritise glucagon-like peptide-1 receptor agonists (GLP-1 RAs) for patients who have the greatest need for the medicines, owing to ongoing shortages of the products.
The EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products said that it had been monitoring shortages of GLP-1 RAs, including Ozempic (semaglutide; Novo Nordisk), Saxenda (liraglutide; Novo Nordisk), Trulicity (dulaglutide; Eli Lilly) and Victoza (liraglutide; Novo Nordisk), since 2022, but that further action was now needed.
In a statement, published on 26 June 2024, the group said that member countries should work with marketing authorisation holders of the drugs to introduce measures “to control and optimise the distribution of these medicines”.
“Member states are also encouraged (together with experts and learned societies) to develop guidelines to facilitate prioritisation of patients who have the greatest need for the medicines,” the statement added.
The EMA also said that marketing authorisation holders must ensure that any promotion of these medicines have been approved by regulatory authorities, adding that “claims made by companies in the context of such activities should align with rational medicine use and public health goals”.
“Marketing authorisation holders should also consider implementing awareness campaigns on weight management and educational activities on the ongoing shortage and its implications for clinical practice,” the statement said.
The EMA said it was holding a workshop on 1 July 2024 for relevant organisations, “including international regulators”, to discuss extra measures to improve the supply of GLP-1 RA medicines in the EU area.
Emer Cooke, executive director of the EMA, said: “We need to step up actions now — industry, regulators, healthcare professionals, patients and the public at large all have a role to play in resolving these shortages and we are appealing to everyone to play their part.”
In June 2023, the UK government declared a “national shortage” of GLP-1 RAs for type 2 diabetes mellitus until 2024, attributing the shortages to “an increase in demand for these products for licensed and off-label indications”.
A spokesperson for the Medicines and Healthcare products Regulatory Agency (MHRA) said that a National Patient Safety Alert on the supply and use of GLP-1 RAs was published in the UK in January 2024.
The spokesperson was unable to confirm whether the MHRA had attended the EMA workshop on 1 July 2024.
