Tuesday, October 12, 2021
PTC Therapeutics, Inc. 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.
Tegsedi 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.
"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."
Studies 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, which is about 10 percent of all cases worldwide.