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Tegsedi® Receives Innovative Drug Category Pricing in Brazil
SOUTH PLAINFIELD, N.J., Oct. 11, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that Tegsedi® (inotersen) has successfully
About this update from Ptc Therapeutics, Inc.
[{"type":"text","content":"SOUTH PLAINFIELD, N.J., Oct. 11, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that Tegsedi® (inotersen) has successfully received Category 1 classification from Câmara de Regulação do Mercado de Medicamentos - CMED (Drug Market Regulation Chamber) in Brazil. Category 1 classification is given to innovative treatments that provide greater efficacy than current standards of care. Category 1 allows for pricing in line with international markets. \n\n \n \n \n \n \n \n\n \nTegsedi has been approved by the Brazilian regulatory agency ANVISA (Agência Nacional de Vigilância Sanitária) for the treatment of Stage 1 or 2 polyneuropathy (nerve damage) in adult patients with hereditary transthyretin-mediated (hATTR) amyloidosis to delay disease progression and improve quality of life. It is the first antisense medicine available for patients in Brazil to address the underlying cause of the disease.\n\"This is an incredibly important decision in allowing patients access to Tegsedi in Brazil,\" said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics. \"Because of the high Portuguese descent, there is a higher prevalence of hATTR patients in the Brazilian population. The disease has a devastating impact on patients and their caregivers, and we are proud to bring an innovative treatment that provides greater efficacy to these patients.\" \nStudies have proven that Tegsedi significantly improved measures of neuropathic disease progression and quality of life for patients.1 There are estimated to be 5,000 patients with hATTR amyloidosis in Brazil,2 which is about 10 percent of all cases worldwide.3\nAbout Tegsedi® (inotersen)Tegsedi is designed to block the production of the TTR protein, which is the underlying cause of hATTR amyloidosis. It is a novel, first-in-class 2'-O-2- methoxyethyl phosphorothioate antisense oligonucleotide and its mechanism of action is distinct from all previous therapies for hATTR amyloidosis. In the Phase 3 NEURO-TTR study, Tegsedi significantly reduced the levels of TTR protein in patients irrespective of mutation type or stage of disease,1 and significantly improved quality of life.1 Tegsedi is a once-weekly, self-administered subcutaneous treatment, which enables greater patient independence. Tegsedi is approved in Brazil, Canada, the European Union, and the United States...