EU Advocates Cooperation, Increased Manufacturing to Address GLP-1 Shortage

As the shortage of widely-used GLP-1 receptor agonists continues across the European Union, the European Medicines Agency (EMA) issued recommendations on Wednesday for member states to share information and apply mitigation strategies until the supply stabilizes. The EMA, along with its Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), also urged pharmaceutical companies Novo Nordisk and Eli Lilly to increase their production capacities for crucial weight loss and diabetes medications.

Novo Nordisk manufactures Ozempic (semaglutide), Wegovy (semaglutide), Saxenda (liraglutide), and Victoza (liraglutide). Similarly, Eli Lilly develops Mounjaro (tirzepatide) and Trulicity (dulaglutide). The EMA emphasized that the shortage began in 2022 due to a spike in demand coupled with manufacturing capacity limitations. Despite efforts, it appears unlikely that these pharmaceutical firms can significantly boost their production in the short term. Over the past year, both companies have invested billions in creating or acquiring new manufacturing facilities.

To address this, the EMA and MSSG have recommended that Novo Nordisk and Eli Lilly collaborate closely with EU member states to enforce controlled distribution policies. These policies would limit the quantity of drugs sold and carefully allocate existing supplies to prioritize patients with the most urgent need. The MSSG also advised member states to collaborate with experts to establish guidelines for patient prioritization while warning against the off-label use of GLP-1 drugs, as this could worsen the shortage.

Furthermore, the agency advised member states to monitor the effectiveness of their chosen mitigation strategies to maximize their benefits across the EU. In addition, the MSSG announced the organization of a workshop on July 1, where international regulators will gather to discuss further measures aimed at improving the supply of GLP-1 medications in Europe.