Akcea Therapeutics Ireland Limited has announced the permanent discontinuation of TEGSEDI (inotersen sodium) 284 mg solution for injection in a pre-filled syringe - AIC 046924027 - in the European Union as of 1 December 2026.

The medicinal product is indicated for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).

The decision is commercial in nature, based on the limited use of the medicinal product and the gradual transition to other available therapies, and is not related to any safety, efficacy, quality or manufacturing issues.

The application to withdraw the marketing authorisation will be submitted on 1 December 2026.

In preparation for the discontinuation, healthcare professionals should:

• not initiate treatment with TEGSEDI in new patients;
• promptly plan the transition of patients currently receiving TEGSEDI to an appropriate authorised and available alternative treatment;
• inform affected patients and ensure continuity of care during the transition period