EMA calls for action to address EU shortage of GLP-1 receptor agonists

The EMA and the Heads of the Medicines Agencies (HMA), through the Medicines Shortages and Safety Executive Steering Group (MSSG), have issued recommendations to address the shortage of the glucagon-like peptide-1 (GLP)-1 receptor agonist Ozempic. (semaglutide), Saxenda (liraglutide), Trulicity (dulaglutide) and Victoza (liraglutide). GLP-1 receptor agonists are licensed for the treatment of diabetes or for weight control in certain conditions, or both.

“Since 2022, rising demand for some of these medicines, as well as other issues such as production capacity limitations, have led to shortages across the EU.”“, the EMA said in a statement.

The EMA and the EU regulatory network are “closely monitoring the situation and taking action from 2022.” “We need meStep up action now: industry, regulators, healthcare professionals, patients and the general public have a role to play in addressing this shortage, and we encourage everyone to do their part.l,” said Emer Cook, chief executive of the EMA.

Member States should, together with marketing authorization holders, consider measures to control and optimize the distribution of these medicinal products. Continued collaboration and cooperation among Member States through the Joint Action Group on Drug Shortages (SPOC WP) will enable the MSSG to obtain a comprehensive overview of the situation and assess the impact of the measures taken. Member States (together with experts and scientific societies) are also encouraged to develop guidelines to facilitate the prioritisation of patients who need medicines most.

To get a full overview of how these drugs are used in real life, MSSG agreed to conduct a real-world data-based study (via DARWIN EU5). The MSSG also recommended that marketing authorization holders increase production capacity and continue to engage with regulators to ensure coordination. Moreover, in accordance with national legislation, lMarketing authorisation holders for GLP-1 receptor agonists must ensure that the advertising they use to promote these products is approved by regulatory authorities. The claims made by companies in the context of such activities must be consistent with the rational use of medicines and public health objectives. Marketing authorization holders should also consider conducting weight loss awareness campaigns and educational events about the current deficiency and its implications for clinical practice.

To gain a full overview of the situation and to discuss and identify possible additional solutions, the MSSG will organise a multi-stakeholder workshop on 1 July 2024. This workshop will bring together all key stakeholders, including international regulators, to discuss additional measures to improve the supply of GLP-1 receptor agonist medicinal products in the EU/EEA.

For healthcare professionals, the EMA reminds that the GLP-1 receptor agonists Bydureon, Byetta, Lyxumia, Ozempic, Rybelsus, Trulicity and Victoza are only indicated in diabetes, while Saxenda and Wegovy are indicated for weight control as an adjunct to diet and exercise. people with obesity or overweight. underlying health problems. Mujaro is approved for both diabetes and weight control under certain conditions. Any other use constitutes unapproved use that would worsen an existing deficiency.

MSSG is concerned about the overuse of some GLP-1 receptor agonists in an off-label manner, which threatens the availability of these drugs for their approved uses with potentially serious consequences for patients. The MSSG therefore recommends that healthcare professionals prescribe these medicines only in accordance with their authorized uses, taking into account the recommendations of national authorities or applicable national therapeutic guidelines.

GLP-1 receptor agonists are not approved and should not be used for cosmetic weight loss, that is, for weight loss in non-obese people or overweight people who do not have weight-related health problems. Health care providers should consider providing lifestyle advice to these individuals.

Likewise, the European Agency warns the general public that these medicines should only be used under medical supervision. It also reminds that “due to the high demand for these medicines, there is a risk that low-quality or counterfeit medicines will be offered online.” Using counterfeit medications can have serious health consequences. To avoid this risk, GLP-1 receptor agonists should not be purchased without a prescription. When purchasing these medicines online, you should only order them from pharmacies registered with the competent national authorities of the EU Member States. More information about buying medicines online in the EU and how to recognize registered pharmacies can be found here: Buying medicines online.