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Akcea announces approval for reimbursement of TEGSEDI® (inotersen) in Italy for treatment of hereditary transthyretin amyloidosis with polyneuropathy
TEGSEDI is the first antisense oligonucleotide medicine available to hATTR patients with polyneuropathy in Italy for at-home subcutaneous injection BOSTON,
About this update from Ionis Pharmaceuticals, Inc.
[{"type":"text","content":"TEGSEDI is the first antisense oligonucleotide medicine available to hATTR patients with polyneuropathy in Italy for at-home subcutaneous injection\n\n\nBOSTON, June 8, 2020 /PRNewswire/ -- Akcea Therapeutics, Inc. (NASDAQ: AKCA), a majority-owned affiliate of Ionis Pharmaceuticals, Inc., today announced that AIFA, or The Italian Medicines Agency, has granted approval for the reimbursement of TEGSEDI® (inotersen) for 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\"The approval of reimbursement for TEGSEDI in Italy is an exciting milestone as people living with hATTR amyloidosis with polyneuropathy will now have a much-needed treatment option available, and one that can be administered at home,\" said Michael Pollock, SVP, head of Europe at Akcea. \n\"We are pleased that following the Italian Medicines Agency's detailed evaluation of TEGSEDI they are recognizing the serious unmet need of hATTR amyloidosis patients in the Country and the significance of the safety and efficacy data demonstrated thus far from this therapy, including positive long-term results from the NEURO-TTR open-label extension study that were recently published in the European Journal of Neurology,\" said Massimo Boriero, VP, general manager of Italy at Akcea. \"We look forward to continue to work with the Italian Medicines Agency to rapidly bring TEGSEDI to appropriate patients.\" \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 silencing the defective gene in these patients and reducing abnormal production of the TTR protein. It is the first antisense oligonucleotide medicine available for patients in Italy with hATTR amyloidosis with polyneuropathy, and also the first treatment available to Italian patients that can be self-administered at home.\n\"hATTR is a complex disease and we understand how important it is for patients to have access t...