EMA Approves Flexible Storage For Wegovy Injection, Reducing Cold Chain Dependence In Europe

The European Medicines Agency has approved an update to the product information for Wegovy injection, allowing it to be stored at up to 30°C for up to 48 hours during delivery. This change significantly eases distribution requirements, making Wegovy the only GLP-1 therapy for weight management in Europe with this level of flexibility.

Previously, Wegovy distribution relied entirely on strict cold chain logistics, requiring continuous refrigeration from manufacturing to patient use. With this new approval, the final stage of delivery, from pharmacies to patients, can now occur within a 48-hour window without refrigeration, provided temperatures do not exceed 30°C.

“Home delivery of medicines is growing rapidly, given the convenience of being able to receive your medicines at your doorstep, which we have come to expect from most other aspects of our lives. People with obesity using prescription medicine may also face stigma, and we are therefore excited about the opportunity to reduce distribution complexity while further enabling discrete home delivery options,” said Mike Doustdar, CEO and president of Novo Nordisk.

This added flexibility is expected to support the growth of eHealth and direct-to-patient delivery models, including online pharmacies and alternative dispensing channels. It may also reduce logistical costs by lowering packaging requirements and minimizing reliance on temperature-controlled transport systems.

The update applies specifically to healthcare providers through changes in the Summary of Product Characteristics (SmPC), with no revisions to patient leaflets. Patients can continue storing the injection for up to 28 days below 30°C after first use. The update does not apply to the Wegovy pill, which does not require refrigeration and is currently approved in the U.S., with a European regulatory decision anticipated later in 2026.