Fiasp® (faster-acting insulin aspart) receives positive opinion from the Committee for Medicinal Products for Human Use for use in adults with diabetes in Europe
Gatwick, UK, 11 November, 2016—Novo Nordisk announced today that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has adopted a positive opinion for Fiasp® (faster-acting insulin aspart), a new formulation of the rapid-acting insulin, NovoRapid® (insulin aspart), that increases the initial insulin absorption rate and fosters an earlier blood-glucose lowering effect, compared to the existing formulation1.
The CHMP positive opinion recommends that faster-acting insulin aspart will be indicated for the treatment of diabetes mellitus in adults1.
This step towards European approval follows positive results from Novo Nordisk’s onset clinical trial programme presented earlier this year2,3. In adults with type 1 diabetes, faster-acting insulin aspart significantly reduced HbA1c versus insulin aspart when dosed at mealtime (estimated treatment difference [ETD]; [95% confidence interval (CI)] -0.15 [-0.23; -0.07]; onset 1 trial)2. In adults with type 2 diabetes, the treatment had comparable HbA1c reduction versus insulin aspart (ETD [95% CI]: -0.02 [-0.15; 0.10]; onset 2 trial)3. For adults with type 1 diabetes, faster-acting insulin aspart had a superior reduction in the rise of 2-hour post-prandial glucose (PPG) increment (ETD [95% CI]: -0.67 [-1.29; -0.04] mmol/L)2 and for adults with type 2 diabetes, it had no significant reduction in the rise of 2-hour PPG increment (ETD [95% CI]: -0.36 [-0.81; 0.08] mmol/L)3.
Dr Mark Evans, Consultant Physician at Addenbrookes Hospital, Cambridge, and Lecturer at Cambridge University, Institute of Metabolic Science commented: “Today’s announcement is an important milestone in bringing people with type 1 or type 2 diabetes across Europe one step closer to being able to use this faster-acting insulin formulation, which may allow them to improve PPG excursions compared with current mealtime insulin. Importantly, better PPG control might then allow people living with diabetes to achieve challenging HbA1c targets.”
Professor David Russell-Jones, primary investigator for onset 1, Consultant Physician at the Royal Surrey County Hospital, and Professor of Diabetes and Endocrinology at the
University of Surrey explained: “Managing PPG levels can be challenging for those living with diabetes, resulting in hyperglycaemic episodes if glucose levels rise too high, particularly after eating. This new mealtime insulin option has proven advantages for people on a basal-bolus regimen compared to the current gold standard rapid-acting insulin, so the positive opinion granted today is a welcome step forward in the overall diabetes treatment landscape”.
Novo Nordisk expects to receive the final marketing authorisation from the European Commission within the coming months.
*Postprandial glucose (PPG) increment is the increase in blood glucose levels after eating
NOTES TO EDITORS
About the onset 1 and onset 2 trials2,3
The onset programme is a phase 3 clinical programme investigating faster-acting insulin aspart. This programme consists of four trials encompassing more than 2,100 people with type 1 or type 2 diabetes.
The onset 1 trial was a 26+26-week randomised, partially double-blind, basal-bolus, treat-to-target trial. This trial investigated faster-acting insulin aspart dosed at mealtime or 20 minutes after starting a meal versus NovoRapid® (insulin aspart) dosed at mealtime, both in combination with a basal insulin (insulin detemir) in 1,143 adults with type 1 diabetes.
The onset 2 trial was a 26-week randomised, double-blind, basal-bolus, treat-to-target trial. This trial investigated faster-acting insulin aspart versus insulin aspart, both dosed at mealtime and in combination with a basal insulin (insulin glargine) and metformin in 689 adults with type 2 diabetes.
In the onset 1 and onset 2 studies, the most commonly reported adverse event associated with faster-acting insulin aspart was hypoglycaemia. No significant difference in the overall rate of severe or confirmed hypoglycaemia in people with type 1 or type 2 diabetes was identified between faster-acting insulin aspart and insulin aspart.
About faster-acting insulin aspart
Faster-acting insulin aspart is a mealtime (bolus) insulin developed by Novo Nordisk for improving blood-glucose control in adults with type 1 or type 2 diabetes. Faster-acting insulin aspart is insulin aspart (NovoRapid®) in a new formulation in which two excipients have been added, a vitamin and an amino acid, to increase the initial absorption rate and foster an earlier blood-glucose lowering effect.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders, and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 41,600 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.co.uk.
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1. Committee for Medicinal Products for Human Use (CHMP). Summary of opinion – Fiasp® (insulin aspart). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004046/WC500216067.pdf. Last accessed November 2016.
2. Russell-Jones D, et al. Double-blind mealtime faster-acting insulin aspart vs insulin aspart in basal-bolus improves glycemic control in T1D: the onset® 1 trial. Oral presentation at: 76th Scientific Sessions of the American Diabetes Association (ADA). June 10-14, 2016; New Orleans, LA.
3. Bowering K, et al. Faster-acting insulin aspart vs insulin aspart as part of basal-bolus therapy improves postprandial glycemic control in uncontrolled T2D in the double-blinded onset® 2 trial. Oral presentation at: 76th Scientific Sessions of the American Diabetes Association (ADA). June 10-14, 2016; New Orleans, LA.
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Telephone: +44 1293 613555
Date of preparation: November 2016
Last updated on: 11/11/2016
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