Pharmaceutical Technology

GLP-1 shortages are not expected to resolve this year, says EMA Director

The EU regulatory agency states that the shortages are due to higher demand and off-label use of GLP-1 receptor agonists.

The glucagon-like peptide 1 (GLP-1) receptor agonists have emerged as blockbuster drugs and have raked in billions in sales. However, the higher demand for these therapies has now led to multiple reports of shortages.

In response to these events, the European Medicines Agency (EMA) has put forth recommendations to tackle the shortages of these GLP-1 receptor agonists like Eli Lilly’s Trulicity (dulaglutide), and Novo Nordisk’s Ozempic (semaglutide), Saxenda (liraglutide) and Victoza (liraglutide).

Another version of semaglutide, marketed as Wegovy, and Eli Lilly’s Mounjaro (tirzepatide) are approved in the EU for weight management in addition to diet and physical activity.

The EMA has recommended that manufacturers and distributors avoid promotional activities for these products until the shortage persists. Cooke noted that EU member states should preserve stock, by controlling/limiting prescriptions. Broich stated that physicians should avoid prescribing GLP-1 receptor agonists for cosmetic use or in obese patients without any co-morbidities or prescribe another class of drugs.

The GLP-1 shortage has been ongoing in the EU since 2022, the year the first anti-obesity drug, Novo Nordisk’s Wegovy (semaglutide) was approved by the EMA. With a growing demand for these therapies along with a difficulty in sc a ling up production, Emer Cooke, EMA’s Executive Director, said she did not expect the GLP-1 shortage to be resolved this year, in a briefing call held earlier today (26 June).

Professor Karl Broich, President of the Federal Institute for Drugs and Medical Devices (BfArM) and chair of the European Heads of Medicines Agencies (HMA) noted that the drug shortage is compounded by the off-label use of these products, during the same call. The regulatory agency has also launched a real-world study to investigate the off-label use of these products, and as per Cooke, preliminary results from the study are expected in August or September.

Whilst Broich ruled out reports of stockpiling of these products by EU member states, he did acknowledge that there are restrictions on the export of GLP-1 agonists.

Cooke also noted that there has been a rise in falsified versions of GLP-1 agonists, especially Ozempic. These falsified versions are mainly prevalent outside the legal system, and available especially through online pharmacies, said Cooke. “There was one report of possible [Ozempic] falsification in the legal supply chain, but those medicines never reached any patients”.