Supply status of GLP-1 analogues

Category: Human Medicines, Supply Issues
Reference: ICM (CONTINUED), 05/2024

The Spanish Agency for Medicines and Health Products (AEMPS) updates the situation regarding supply problems of GLP-1 analogues and updates some recommendations for healthcare professionals. In 2022, AEMPS had already published a number of measures to prevent or mitigate supply problems for these drugs, particularly for Trulicity and Ozempic, in its various presentations, and then updated them on September 8, 2023.

GLP-1 analogue drugs are approved to improve glycemic control in the treatment of adults with type 2 diabetes mellitus (T2DM) that is not well controlled by diet and exercise. These drugs are indicated in monotherapy – when metformin is not considered suitable due to intolerance or contraindications – or in combination with other drugs used to treat diabetes. In addition, some GLP-1 analogues are also approved for weight control in certain situations.

Until now, only Saxenda has been approved for weight management indications, but several new drug launches, Wegovy, have recently been approved and are expected to go on sale from May 2024. In both cases, the indication for weight control is weight loss. always in combination with a healthy diet and increased physical activity.

On the other hand, two drugs from the same therapeutic group that were indicated as alternatives have ceased marketing: Byetta and Lyxumia.

Despite these measures to mitigate the impact of high demand for these diabetes products, patients continue to suffer from supply problems that began in late 2022. Therefore, AEMPS reminds you to adjust your recipes to prioritize use. of these treatments for glycemic control in patients with T2DM, as therapeutic alternatives for these patients may be more challenging.

On the other hand, the inspection services of autonomous entities have identified cases of prescription of these drugs for indications not included in their technical data sheet, or without compliance with the indications of the competent authorities. Cases have also been identified where they are released without an appropriate medical prescription. This may entail administrative liability provided for by law.

Operating laboratories continue to work on measures to increase their global production to meet demand, but while this occurs, supply tensions may continue to arise.

To facilitate monitoring of these types of issues, AEMPS maintains a list of active supply issues that is continually updated.

Information for prescribers

Prioritize the use of these treatments according to authorized conditions. Specifically for glycemic control in patients with T2DM.

As far as possible, do not start new treatments until owners have confirmed that they can meet demand on a sustainable basis.

While supply problems remain, and given the possibility of failure to initiate or continue treatment for T2DM, AEMPS recommends substituting treatment with another available drug from the same therapeutic group:

• Ribelsus (semaglutide; administered orally once daily on an empty stomach with half a glass of water and kept for at least 30 minutes before eating, drinking, or taking other oral medications).

If it is necessary to replace GLP-1 analogue treatment with one of these alternatives, please note that:

• New treatment should be started one week after the last dose of Ozempic/Trulicity, and in the case of Victoza, one day after the last dose of Victoza.
• If GLP-1 treatment is already established, a maintenance dose of the new drug can be started without the need for starting doses.
• Tighter glycemic control is recommended during the first weeks after replacement.

We remind you that Saxenda injection solution 6 mg/ml in a pre-filled pen is available for weight control, as indicated in its technical data sheet. Similarly, Wegovy flextouch injection solution is planned to be available in a pre-filled pen from May 2024.

Information for pharmacists

Remember that these medications should never be dispensed without an appropriate prescription.