Insulin icodec represents a significant advancement with its once-weekly dosing. Can you discuss the decision to focus on its development, particularly considering its benefits for patients with renal or hepatic conditions?
For more than 100 years, Novo Nordisk has been dedicated to developing innovative medicines as part of our purpose to drive change to address the world’s most pressing health needs, including diabetes. As we continue to transform and evolve, our core commitment to people living with chronic diseases remains at the center of everything we do as a team.
Insulin icodec is another example of our continued innovation: an investigational once-weekly basal insulin analog designed to cover the basal insulin requirements for a full week with a single subcutaneous injection. If approved, insulin icodec may have the potential to redefine insulin therapy and help reinvent the insulin start experience for adults living with diabetes.
Pending approval, insulin icodec would represent the first and only once-weekly basal insulin option for adults with diabetes in the US, and the once-weekly dosing may help significantly reduce the treatment burden for patients. For many, insulin remains a cornerstone of diabetes treatment, and this may help improve patient adherence while also helping to reduce the risk of diabetes-related complications that arise with uncontrolled blood sugar levels.
Based on positive efficacy and safety data from the ONWARDS clinical trial program, we submitted a biologics license application (BLA) in April 2023 to the US Food & Drug Administration (FDA) for once-weekly insulin icodec for the treatment of diabetes.
People with varying degrees of renal and hepatic impairment participated in dedicated trials and no specific dose adjustments for insulin icodec were required in these individuals using insulin icodec. Insulin therapy should always be individualized – and any decisions about care should always be made together with a healthcare professional, who know their patients' past and current medical history and are best equipped to make clinical recommendations.
With Novo Nordisk expanding focus to Alzheimer's and chronic kidney disease, beyond diabetes and weight management, what motivates this shift, and how do you envision the company's role in treating these conditions?
For Team Novo Nordisk – we are at an incredible moment in time. Last year we celebrated our 100th anniversary – a milestone few companies reach. Our relentless pursuit of scientific innovation in diabetes and obesity care has given us the expertise and capabilities to tackle other serious chronic diseases as we look toward the next 100 years. We are at an incredibly exciting inflection point as an organization as we transition from a focus of four therapeutic areas to potentially 10 therapeutic areas over the next five to 10 years.
Our priority is to advance scientific understanding and treatment options in our core therapy areas while diversifying our pipeline. Some highlights include:
- In cardiovascular disease, we recently announced the FDA approval of Wegovy® to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight along with a reduced calorie diet and increased physical activity. Additionally, we are focusing our research and development on atherosclerotic cardiovascular disease (high cholesterol, systemic inflammation and uncontrolled hypertension) and heart failure. Our late-stage clinical pipeline in these areas is investigating options for significant patient unmet need, pursuing innovative mechanisms of action, and combining internal and external innovation.
- In Metabolic Dysfunction-associated Steatohepatitis (MASH), we are leveraging our expertise in obesity and type 2 diabetes with an ambition to develop new treatment options that address liver damage in people living with MASH. We are also supporting the advancement of non-invasive diagnostic tests to help address challenges in screening, diagnosing and monitoring prognosis of MASH.
- In Alzheimer’s disease, due to the growing unmet medical need, we are investigating oral semaglutide in early Alzheimer’s disease, specifically in stages of mild cognitive impairment and mild dementia.
What is the significance of the new indication for Wegovy®? Will this impact price of the product or coverage?
Decades ago, Novo Nordisk took a stand that obesity is a disease, and the shame in our society needs to stop. We are committed to driving meaningful change - and it’s not just about effective medicines but other real barriers like stigma and bias. Because obesity is not a personal failing; it’s a matter of health – and people deserve respect, support and care.
The recent additional indication for Wegovy® is based on the result of the landmark SELECT trial. It is a pivotal step forward in addressing some of the most pressing health issues of our time. Wegovy® is the first-and-only medicine indicated for both reduction of the risk of major adverse cardiovascular events (MACE) such as death, heart attack or stroke and for long term weight management in appropriate patients.
We recognize how important this moment is for the millions of people who live with overweight or obesity and known heart disease, and we will continue to advance options that put their needs first.
Although we can’t speculate on future coverage decisions by insurance providers, we are hopeful as to what this indication means. For example, CMS recently released guidance that has the potential to lead to Wegovy® coverage for millions of Medicare Part D patients with obesity and known heart disease. We continue to advocate for patients and policies that support access to all obesity treatments.
