BAGSVAERD, Denmark I December 20, 2013 I Novo Nordisk today announced two separate regulatory submissions for a 3 mg dose of liraglutide, a once-daily human GLP-1 analogue, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity, or who are overweight with comorbidities. The company filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA).
The submissions for liraglutide 3 mg include data from the Phase 3 SCALET clinical trial programme, which involved more than 5,000 people with obesity (BMI ?30 kg/m2), or who are overweight (BMI ?27 kg/m2) with comorbidities. In addition to the data from the SCALET programme, data from earlier development phases and data related to the use of liraglutide in type 2 diabetes were also included in the submissions.
Data from the SCALET clinical trial programme have consistently demonstrated that liraglutide 3 mg, in combination with diet and exercise, induces and maintains weight loss, while also significantly improving obesity-related comorbidities such as hypertension, dyslipidaemia and sleep apnoea. Furthermore, in people with obesity and type 2 diabetes or prediabetes, trials have demonstrated that liraglutide 3 mg significantly improves glycaemic control, in addition to lowering weight.
“We believe that liraglutide 3 mg has the potential to make a significant difference in the management of obesity by providing both a sustainable weight loss and an improvement in several obesity-related comorbidities”, said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
About obesity
Obesity is a disease that requires chronic management. It is often linked to serious comorbidities – including type 2 diabetes, heart disease, obstructive sleep apnoea and certain types of cancer – accompanied by a decreased life expectancy of 5-10 years. The risk of morbidity and mortality increases with the severity of obesity. It is a complex and multifactorial disease, influenced by genetic, physiological, environmental and psychological factors.
The global increase in the prevalence of obesity is a public health issue with huge cost implications to healthcare systems. In the US, approximately 35% of adults, or some 100 million people are obese. A sustained weight loss of 5-10% has been shown to be associated with significant health benefits.
About liraglutide 3 mg
Liraglutide 3 mg is a once-daily GLP-1 analogue with 97% homology to naturally occurring human GLP-1. Like human GLP-1, liraglutide 3 mg regulates appetite by increasing feelings of fullness and reducing feelings of hunger, allowing people to feel satisfied with eating less. GLP-1 also plays an important role in maintaining normal blood glucose levels. This dual action of GLP-1 holds therapeutic potential for the treatment of people with obesity. Liraglutide 3 mg is not an approved treatment.
Liraglutide is currently approved and marketed at lower doses (1.2 and 1.8 mg once-daily, as well as 0.9 mg in Japan) for type 2 diabetes, under the brand name Victoza®. Victoza® is not approved for weight management and should not be prescribed for this treatment.
About the SCALET clinical programme
SCALET (Satiety and Clinical Adiposity – Liraglutide Evidence in Non-diabetic and Diabetic people) consists of four trials encompassing more than 5,000 people who are overweight (BMI ?27 kg/m2) and with comorbidities such as hypertension, dyslipidaemia, or type 2 diabetes, or who have obesity (BMI ?30 kg/m2) with or without comorbidities. In addition to demonstrating safety and efficacy for weight management with liraglutide 3 mg, each of the four trials had a specific focus:
SCALET Obesity and Prediabetes (3,731 people randomised) – a 56-week and 160-week randomised, placebo-controlled trial in people with obesity, or overweight people with comorbidities, designed to demonstrate clinically meaningful and safe weight loss after 56 weeks of treatment with liraglutide 3 mg. The 56-week results were reported in May 2013. The 160-week extension study is ongoing and investigates the long-term effect of liraglutide 3 mg, in combination with diet and exercise, on the progression to type 2 diabetes.
SCALET Maintenance (422 people randomised) – a 56-week randomised, placebo-controlled trial designed to show maintenance of weight loss in people with obesity or overweight people with comorbidities, who have successfully achieved a 5% or greater weight loss during a three-month run-in period that included a lifestyle intervention programme of low-calorie diet and exercise alone. The results of SCALET Maintenance were reported in 2010.
SCALET Diabetes (846 people randomised) – a 56-week randomised, placebo-controlled trial designed to demonstrate clinically meaningful and safe weight loss with liraglutide
3 mg in people with obesity, or overweight people with type 2 diabetes. The results of SCALET Diabetes were reported in March 2013.
SCALET Sleep Apnoea (359 people randomised) – a 32-week randomised, double-blind, placebo-controlled trial in people with obesity with moderate or severe obstructive sleep apnoea (OSA) to investigate the effect of liraglutide 3 mg, in combination with diet and exercise, in reducing the severity of OSA. The results of SCALET Sleep Apnoea were reported in August 2013.
Novo Nordisk is a healthcare company and a world leader in diabetes care.
In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society.
SOURCE: Novo Nordisk
Post Views: 1,207
BAGSVAERD, Denmark I December 20, 2013 I Novo Nordisk today announced two separate regulatory submissions for a 3 mg dose of liraglutide, a once-daily human GLP-1 analogue, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity, or who are overweight with comorbidities. The company filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA).
The submissions for liraglutide 3 mg include data from the Phase 3 SCALET clinical trial programme, which involved more than 5,000 people with obesity (BMI ?30 kg/m2), or who are overweight (BMI ?27 kg/m2) with comorbidities. In addition to the data from the SCALET programme, data from earlier development phases and data related to the use of liraglutide in type 2 diabetes were also included in the submissions.
Data from the SCALET clinical trial programme have consistently demonstrated that liraglutide 3 mg, in combination with diet and exercise, induces and maintains weight loss, while also significantly improving obesity-related comorbidities such as hypertension, dyslipidaemia and sleep apnoea. Furthermore, in people with obesity and type 2 diabetes or prediabetes, trials have demonstrated that liraglutide 3 mg significantly improves glycaemic control, in addition to lowering weight.
“We believe that liraglutide 3 mg has the potential to make a significant difference in the management of obesity by providing both a sustainable weight loss and an improvement in several obesity-related comorbidities”, said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
About obesity
Obesity is a disease that requires chronic management. It is often linked to serious comorbidities – including type 2 diabetes, heart disease, obstructive sleep apnoea and certain types of cancer – accompanied by a decreased life expectancy of 5-10 years. The risk of morbidity and mortality increases with the severity of obesity. It is a complex and multifactorial disease, influenced by genetic, physiological, environmental and psychological factors.
The global increase in the prevalence of obesity is a public health issue with huge cost implications to healthcare systems. In the US, approximately 35% of adults, or some 100 million people are obese. A sustained weight loss of 5-10% has been shown to be associated with significant health benefits.
About liraglutide 3 mg
Liraglutide 3 mg is a once-daily GLP-1 analogue with 97% homology to naturally occurring human GLP-1. Like human GLP-1, liraglutide 3 mg regulates appetite by increasing feelings of fullness and reducing feelings of hunger, allowing people to feel satisfied with eating less. GLP-1 also plays an important role in maintaining normal blood glucose levels. This dual action of GLP-1 holds therapeutic potential for the treatment of people with obesity. Liraglutide 3 mg is not an approved treatment.
Liraglutide is currently approved and marketed at lower doses (1.2 and 1.8 mg once-daily, as well as 0.9 mg in Japan) for type 2 diabetes, under the brand name Victoza®. Victoza® is not approved for weight management and should not be prescribed for this treatment.
About the SCALET clinical programme
SCALET (Satiety and Clinical Adiposity – Liraglutide Evidence in Non-diabetic and Diabetic people) consists of four trials encompassing more than 5,000 people who are overweight (BMI ?27 kg/m2) and with comorbidities such as hypertension, dyslipidaemia, or type 2 diabetes, or who have obesity (BMI ?30 kg/m2) with or without comorbidities. In addition to demonstrating safety and efficacy for weight management with liraglutide 3 mg, each of the four trials had a specific focus:
SCALET Obesity and Prediabetes (3,731 people randomised) – a 56-week and 160-week randomised, placebo-controlled trial in people with obesity, or overweight people with comorbidities, designed to demonstrate clinically meaningful and safe weight loss after 56 weeks of treatment with liraglutide 3 mg. The 56-week results were reported in May 2013. The 160-week extension study is ongoing and investigates the long-term effect of liraglutide 3 mg, in combination with diet and exercise, on the progression to type 2 diabetes.
SCALET Maintenance (422 people randomised) – a 56-week randomised, placebo-controlled trial designed to show maintenance of weight loss in people with obesity or overweight people with comorbidities, who have successfully achieved a 5% or greater weight loss during a three-month run-in period that included a lifestyle intervention programme of low-calorie diet and exercise alone. The results of SCALET Maintenance were reported in 2010.
SCALET Diabetes (846 people randomised) – a 56-week randomised, placebo-controlled trial designed to demonstrate clinically meaningful and safe weight loss with liraglutide
3 mg in people with obesity, or overweight people with type 2 diabetes. The results of SCALET Diabetes were reported in March 2013.
SCALET Sleep Apnoea (359 people randomised) – a 32-week randomised, double-blind, placebo-controlled trial in people with obesity with moderate or severe obstructive sleep apnoea (OSA) to investigate the effect of liraglutide 3 mg, in combination with diet and exercise, in reducing the severity of OSA. The results of SCALET Sleep Apnoea were reported in August 2013.
Novo Nordisk is a healthcare company and a world leader in diabetes care.
In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society.
SOURCE: Novo Nordisk
Post Views: 1,207
