Key Summary
- The MHRA exemption applies only to Wegovy FlexTouch injection.
- This makes Wegovy the first GLP-1 drug in the UK for get such an approval.
- The reduced dependence on cold chain transport for Wegovy is expected to lessen the environmental footprint.
The Medicines and Healthcare products Regulatory Agency (MHRA) has now exempted Novo Nordisk's Wegovy (semaglutide injection) FlexTouch from full 'cold chain' requirement during transit.
The regulator has approved an update to the product information for Wegovy that allows for controlled shipment at temperatures below 30°C for up to 48 hours.
However, this exemption applies only to Wegovy FlexTouch injection.
This makes Wegovy the first GLP-1 drug in the UK to get such an approval, and this comes after the European Medicines Agency (EMA) also approved the product information update on 12 April.
This will reduce distribution complexity and support the reliability of home delivery models for pharmacies and online partners.
Until now, while transporting Wegovy, the full 'cold chain' requirement was mandatory from where it is made to where it is used.
The latest approval provides flexibility for the final stage: delivery of Wegovy from pharmacies to patients can occur within a 48-hour window at temperatures up to 30°C.
In the UK there is increasing adoption of direct-to-patient distribution models, including delivery through online pharmacies and other non-traditional dispensing channels.
The reduced dependence on cold chain transport for Wegovy is expected to lessen the environmental footprint by reducing packaging volume and weight, as well as providing new delivery options for pharmacies and online partners.
“Across the UK, pharmacists and other healthcare providers are increasingly using direct delivery of medicines to patients' homes. We welcome the approval by the MHRA, which will help these providers reduce delivery complexities, supporting efficiency and sustainability in the final stage of delivery to patients,” said Sebnem Avsar Tuna, General Manager, Novo Nordisk UK.
The approved update to the Summary of Product Characteristics (SmPC) for Wegovy is aimed at healthcare providers, including doctors and pharmacists, while there is no change to the patient leaflets.
