New Diabetes Drug Approvals

The incidence of diabetes in the United States continues to rise, climbing to 9.3% of the U.S. population or approximately 29.1 million Americans in 2012.¹ If this trend continues to escalate, estimates predict up to 52% of American adults will be living with diabetes by 2020.²

The recent United States Food and Drug Administration approvals of Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) appear to offer additional or alternative options for both providers and patients when it comes to the effective and long-term management of diabetes. Tresiba is a long-acting insulin analog that is injected subcutaneously once daily, whereas Ryzodeg can be administered either once or twice daily.

The use of long-acting insulins to better manage diabetes symptoms and achieve improved glycemic control is not a novel therapeutic approach for treatment of diabetes, but the use of Tresiba for both type 1 and type 2 diabetes is a characteristic that draws the attention of both providers and patients. The landscape for diabetes management has widened with the approval of these two diabetic drugs, but their efficacy has not been shown to be superior to that of other long-acting insulin products on the market. Rather, it has been reported that the reduction in HbA1C for Tresiba was comparable to that of other insulin agents. The observed benefits of Tresiba and Ryzodeg have been described as being similar to current agents on the market, and even Tresiba was found to offer no additional benefit over existing insulins, according to reports made by the German Institute for Quality and Efficiency Healthcare in 2014.³

Ultimately, with increased awareness, the outcomes of postmarketing evaluations, and additional trials, these two agents have the potential to overtake agents that are currently being prescribed by most providers and used by most patients to manage their diabetes on a daily basis. At this point in time it is too soon to predict the impact that Tresiba and Ryzodeg will have on the diabetes market. Only time will tell if they have the power to change prescribing habits or fail to have a significant impact both on the market and in clinical practice.

References:

1. Centers for Disease Control. National diabetes statistics report, 2014. Accessed 23 Oct 2015 at http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf

2. Diabetes Advocacy Alliance. Diabetes facts and figures – the future. Accessed 23 Oct 2015 at http://www.diabetesadvocacyalliance.org/html/resources_diabetes_facts_future.html

3. Institute for Quality and Efficiency in Health Care. Insulin degludec (Tresiba) for diabetes mellitus. Accessed 23 Oct 2015 at http://www.informedhealthonline.org/insulin-degludec-tresiba-for-diabetes-mellitus.2736.en.html