Swissmedic has granted authorization for Tegsedi (inotersen) for the treatment of stage 1 or 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). This decision, announced on December 6, 2024, aims to address the nerve damage associated with this rare genetic disease.
hATTR is characterized by the accumulation of amyloid proteins in body tissues, including nerves, leading to impaired function. Tegsedi works by reducing the production of transthyretin (TTR) in the liver, thereby decreasing the formation of harmful protein deposits. This mechanism of action targets the underlying cause of the disease, offering a potential therapeutic benefit for affected individuals.
Tegsedi is classified as an antisense oligonucleotide inhibitor. The drug is administered as a solution for injection in a pre-filled syringe. Given the life-threatening nature and rarity of hATTR, Tegsedi has been designated as an orphan drug, which facilitates its expedited review and approval.
Swissmedic's authorization was granted under Article 13 of the Therapeutic Products Act (TPA), leveraging the prior assessment and approval by the European Medicines Agency (EMA; reference number EMA/381704/2018). This approach allows Swissmedic to expedite the availability of medicines already approved in other countries with comparable regulatory standards, ensuring timely access for Swiss patients. Swissmedic conducted a limited scientific review, relying on the EMA's comprehensive evaluation of the drug's quality, efficacy, and safety.
Further details regarding Tegsedi, including information for healthcare professionals and patients, are available. Swissmedic continues to monitor the safety and efficacy of Tegsedi and will take appropriate action if any new safety concerns arise.
