Tegsedi

The company marketing Tegsedi, Akcea Therapeutics Ireland Ltd., is permanently discontinuing the medicine for commercial reasons, in particular low use of the medicine due to the availability of other suitable treatments. The medicine will therefore be unavailable in the EU as of the end of 2026.

The discontinuation is not related to a quality defect of the product or a safety issue.

The discontinuation affects all Member States where the product is marketed: Austria, Bulgaria, France, Germany, Greece, Ireland, Italy, Luxembourg, Poland, Portugal, Spain and Sweden.  

For up-to-date information about the status of a medicine shortage in a particular Member State, consult the national shortage register, where available, or contact the national competent authority.

EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and EMA’s shortages working party (Medicines Shortages Single Point of Contact – SPOC - working party) are closely monitoring the supply situation and engaging with the marketing authorisation holder to mitigate the impact of the supply shortage. 

The SPOC Working Party Supports EMA’s MSSG and monitors and reports events that could affect the supply of medicines in the EU.

• Do not start new patients on Tegsedi.
• Transition all patients who are currently taking Tegsedi to an appropriate treatment alternative for stage 1 or stage 2 polyneuropathy due to hATTR.
• A medicine shortage communication (MSC) will be sent to healthcare professionals in affected Member States and will also be published on the EMA website.
• For additional information consult your country’s shortage register, where available, or contact your national competent authority.
• You may also contact relevant healthcare professional organisations for further information. A list of European not-for-profit organisations EMA engages with can be found on the EMA website.

• If you are taking Tegsedi, your doctor will switch you to a suitable treatment alternative.
• If you were due to start treatment with this medicine, your doctor will prescribe you a suitable alternative.
• If you have any questions, speak to your doctor or pharmacist. 
• For additional information, consult your country’s shortage register, where available, or contact your national competent authority. 
• You may also contact relevant patients’ organisations for further information or support. A list of European not-for-profit organisations that EMA engages with can be found on the EMA website.