The European Medicines Agency (EMA) has communicated the permanent discontinuation of TEGSEDI (inotersen sodium, 284 mg solution for injection in prefilled syringe) in the European Union, effective from 1 December 2026. The decision, taken by marketing authorisation holder Akcea Therapeutics Ireland Limited, is based on low utilisation of the product and natural attrition to other therapies, and is not related to safety, efficacy, or quality concerns.
The discontinuation affects all EU countries where TEGSEDI is marketed: Austria, Bulgaria, France, Germany, Greece, Ireland, Italy, Luxembourg, Poland, Portugal, Spain, and Sweden. National withdrawal submissions will be carried out according to national lead time requirements. The marketing authorisation withdrawal submission is planned for 1 December 2026.
Healthcare professionals are advised not to prescribe TEGSEDI to new patients and to transition current patients to an appropriate commercially available treatment alternative for stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). The company believes the withdrawal will not deprive patients of appropriate treatment, as several approved alternatives are available.
The EMA's shortage catalogue and national competent authorities can provide additional information. The marketing authorisation holder is engaging with EMA and national authorities to ensure sufficient time for preparation. Adverse drug reactions may be reported to the company via adverseevent@ionis.com. The distributor Sobi can be contacted for medical information at +46 8 697 20 00 or medical.info@sobi.com.