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Akcea Announces Approval for Reimbursement of TEGSEDI® (inotersen) in Spain for Treatment of Hereditary Transthyretin Amyloidosis with Polyneuropathy
TEGSEDI is the first antisense medicine available to patients in Spain for at-home subcutaneous injection Approval Issued by Ministry of Health of Spain Only
About this update from Ionis Pharmaceuticals, Inc.
[{"type":"text","content":"TEGSEDI is the first antisense medicine available to patients in Spain for at-home subcutaneous injection\n Approval Issued by Ministry of Health of Spain Only Six Months After Submission\n\n\nBOSTON, May 14, 2020 /PRNewswire/ -- Akcea Therapeutics, Inc. (NASDAQ: AKCA), a majority-owned affiliate of Ionis Pharmaceuticals, Inc., today announced The Ministry of Health of Spain (MSCBS) has granted approval for the reimbursement of TEGSEDI® (inotersen) in the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin (hATTR) amyloidosis. \n\n \n \n \n \n \n \n\n \n\"We appreciate the Ministry of Health's thorough evaluation of TEGSEDI and rapid approval to make this treatment option available to people living with hATTR amyloidosis with polyneuropathy in Spain,\" said Michael Pollock, SVP, head of Europe at Akcea. \"This milestone highlights the strength of the clinical data supporting TEGSEDI and the critical need in the hATTR amyloidosis community for a subcutaneous treatment option that allows patients to self-administer at a time and place that works for them. The data from the NEURO-TTR study showing benefits in measures of neuropathy and quality of life underlines the potential of this therapy to benefit patients in the years ahead. We will continue to collaborate with the Ministry of Health to make TEGSEDI available to patients in Spain as soon as possible.\" \nhATTR amyloidosis is an under-recognized, debilitating and progressive disease that is caused by the buildup of TTR proteins that misfold due to inherited genetic mutations. It is characterized by the deposition of amyloid fibrils throughout the body including in nervous tissue and can have a devastating impact on patients' quality of life. \nTEGSEDI is a once-weekly, at-home subcutaneous injection that targets the polyneuropathy of hATTR amyloidosis at its source by reducing production of the TTR protein. It is the first antisense medicine available for patients in Spain with hATTR amyloidosis with polyneuropathy, and also the first at-home treatment available to Spanish patients.\nThe Ministry of Health's positive opinion of reimbursement for TEGSEDI was based on results from the Phase 3 NEURO-TTR study in patients with hATTR amyloidosis with symptoms of polyneuropathy. Results from that study demonstrated that patients treated wit...