EU Calls for Cooperation and Increased Manufacturing to Overcome GLP-1 Shortage
1. GLP-1 Shortages Persist: The European Medicines Agency (EMA) has stated that shortages of GLP-1 receptor agonists, used for diabetes and weight management, are not expected to resolve this year due to high demand and off-label use.
2. Causes of Shortages: The surge in demand, manufacturing capacity constraints, and off-label use for cosmetic weight loss have contributed to the ongoing shortages.
3. Regulatory Actions: The EMA has issued recommendations to tackle the shortages, including refraining from promotional activities, controlling prescriptions, and increasing manufacturing capacity.
4. Real-World Study: A study is underway to investigate the off-label use of GLP-1 receptor agonists, with preliminary findings expected in August or September.
5. Multistakeholder Workshop: The EMA is organizing a workshop on July 1, 2024, to discuss additional measures to improve the supply of GLP-1 receptor agonist medicines in the EU.
6. Falsified Products: There has been a rise in falsified versions of GLP-1 agonists, particularly Ozempic, mainly available through online pharmacies.