Afrezza® Inhalation Powder Approved in Brazil! =)
Jun 3, 2019 7:03:43 GMT -5
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Post by kite on Jun 3, 2019 7:03:43 GMT -5
www.globenewswire.com/news-release/2019/06/03/1863179/0/en/Afrezza-insulin-human-Inhalation-Powder-Approved-in-Brazil.html
Afrezza® is the only orally inhaled ultra rapid-acting mealtime insulin approved by ANVISA in Brazil. The innovative delivery system reduces injections while improving glycemic control in adult patients with diabetes
WESTLAKE VILLAGE, Calif. and BELO HORIZONTE, Brazil, June 03, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) and BIOMM SA (BVMF:BIOM3) today announced that Afrezza® (insulin human) Inhalation Powder, an ultra rapid-acting mealtime insulin to improve glycemic control in adult patients with diabetes mellitus, has been registered by the Brazilian Health Regulatory Agency (ANVISA). The commercialization of Afrezza in Brazil is expected to begin in the fourth quarter this year, subject to the pricing registration process by Câmara de Regulação do Mercado de Medicamentos (CMED).
“The regulatory approval of Afrezza in Brazil is an important milestone for MannKind and our partner Biomm. It not only represents our first international approval of Afrezza, but more importantly, we now have the opportunity to bring a novel mealtime insulin therapy to patients in a country with one of the highest prevalence of diabetes in the world, according to the International Diabetes Federation,” said Michael Castagna, Chief Executive Officer of MannKind Corporation.
Afrezza is an ultra rapid-acting orally inhaled insulin therapy indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered using a small, discreet and easy-to-use inhaler. Administered at the start of a meal, Afrezza dissolves rapidly upon inhalation to the deep lung and passes quickly into the bloodstream (in less than one minute). Glucose-lowering effects are achieved within minutes of administration, and clinical data with Afrezza demonstrates proven efficacy and safety in the treatment of both type 1 and type 2 diabetes.
“Insulin was first isolated and purified for clinical use in 1923 and now, almost 100 years later, we are excited that patients in Brazil are expected to soon have access to Afrezza, the only non-injectable oral insulin available in the market,” said Heraldo Marchezini, President Director/CEO of Biomm SA. “We believe that Afrezza, with its distinct time-action profile and route of administration, will address many of the unmet needs for mealtime insulin therapy and has the potential to change the way that diabetes is treated. As a pioneering biotechnology company, we are proud to leverage our portfolio of diabetes products and offer another option to treat the significant and growing numbers of patients with diabetes in Brazil.”
Currently, diabetes mellitus affects 425 million adults worldwide, including more than 12 million in Brazil, according to the International Diabetes Federation. Diabetes mellitus is characterized by the body's inability to regulate levels of blood glucose properly. Insulin, a hormone produced by the pancreas, normally regulates the body's glucose levels, but in people with diabetes mellitus insufficient levels of insulin are produced or the body fails to respond adequately to the insulin it produces.
Afrezza® is the only orally inhaled ultra rapid-acting mealtime insulin approved by ANVISA in Brazil. The innovative delivery system reduces injections while improving glycemic control in adult patients with diabetes
WESTLAKE VILLAGE, Calif. and BELO HORIZONTE, Brazil, June 03, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) and BIOMM SA (BVMF:BIOM3) today announced that Afrezza® (insulin human) Inhalation Powder, an ultra rapid-acting mealtime insulin to improve glycemic control in adult patients with diabetes mellitus, has been registered by the Brazilian Health Regulatory Agency (ANVISA). The commercialization of Afrezza in Brazil is expected to begin in the fourth quarter this year, subject to the pricing registration process by Câmara de Regulação do Mercado de Medicamentos (CMED).
“The regulatory approval of Afrezza in Brazil is an important milestone for MannKind and our partner Biomm. It not only represents our first international approval of Afrezza, but more importantly, we now have the opportunity to bring a novel mealtime insulin therapy to patients in a country with one of the highest prevalence of diabetes in the world, according to the International Diabetes Federation,” said Michael Castagna, Chief Executive Officer of MannKind Corporation.
Afrezza is an ultra rapid-acting orally inhaled insulin therapy indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered using a small, discreet and easy-to-use inhaler. Administered at the start of a meal, Afrezza dissolves rapidly upon inhalation to the deep lung and passes quickly into the bloodstream (in less than one minute). Glucose-lowering effects are achieved within minutes of administration, and clinical data with Afrezza demonstrates proven efficacy and safety in the treatment of both type 1 and type 2 diabetes.
“Insulin was first isolated and purified for clinical use in 1923 and now, almost 100 years later, we are excited that patients in Brazil are expected to soon have access to Afrezza, the only non-injectable oral insulin available in the market,” said Heraldo Marchezini, President Director/CEO of Biomm SA. “We believe that Afrezza, with its distinct time-action profile and route of administration, will address many of the unmet needs for mealtime insulin therapy and has the potential to change the way that diabetes is treated. As a pioneering biotechnology company, we are proud to leverage our portfolio of diabetes products and offer another option to treat the significant and growing numbers of patients with diabetes in Brazil.”
Currently, diabetes mellitus affects 425 million adults worldwide, including more than 12 million in Brazil, according to the International Diabetes Federation. Diabetes mellitus is characterized by the body's inability to regulate levels of blood glucose properly. Insulin, a hormone produced by the pancreas, normally regulates the body's glucose levels, but in people with diabetes mellitus insufficient levels of insulin are produced or the body fails to respond adequately to the insulin it produces.
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