Digest

This podcast episode focuses on the ongoing advocacy efforts to ensure continued access to Levemir insulin, which was discontinued in the US. Allison Smart shares her personal journey and the progress made, including bipartisan congressional support and positive FDA interactions. The discussion delves into the critical role of Levemir in managing diabetes during pregnancy, explaining its pharmacokinetic advantages over other insulins. It also explores the complexities of engaging with pharmaceutical companies like Novo Nordisk and the FDA, the challenges of insulin manufacturing, and the strategies employed in building support for Levemir. The episode emphasizes the life-or-death importance of insulin access and encourages listeners to support the cause through the "Alliance to Protect Insulin Choice.org." It also features sponsor messages for the Eversense 365 CGM and promotes a private Facebook group and the "Juice Cruise 2026."

Outlines

00:00:00

Introduction to Levemir Advocacy and Small Sips Series

The podcast welcomes Allison Smart to discuss Levemir insulin and introduces the "Small Sips" series for diabetes management advice. The episode highlights the ongoing advocacy efforts to ensure continued access to Levemir insulin, two years after its discontinuation announcement in the US.

00:01:29

Sponsor: Eversense 365 CGM and Levemir Advocacy Progress

This segment introduces the Eversense 365 CGM and details the significant progress in Levemir insulin advocacy, including bipartisan congressional support, positive FDA meetings, and physician outreach.

00:39:47

The Crucial Role of Levemir in Pregnancy and Advocacy Challenges

The vital importance of Levemir for managing gestational and type 2 diabetes during pregnancy is emphasized due to its stable profile and proven efficacy. The discussion explores the complexities of engaging with Novo Nordisk and the FDA, highlighting the impact of influential voices and the need for persistent advocacy.

00:06:42

Building Support and Personal Advocacy Journey for Levemir

Strategies for building support for Levemir, including engaging congressional staff, physicians, and constituents, are discussed. Allison shares her personal journey, starting with her daughter's Type 1 diabetes diagnosis and subsequent advocacy for Levemir access.

00:13:11

Understanding Insulin Types, Pharmacokinetics, and Manufacturing Complexities

A detailed explanation of different insulin types and their pharmacokinetic differences is provided, focusing on Levemir's unique properties. The challenges and intricacies of insulin manufacturing are discussed, contrasting with the idea of simple replication and highlighting the need for manufacturer assistance.

00:25:31

Advocacy Momentum, Future Outlook, and Call to Action

Recent momentum in Levemir advocacy is attributed to increased physician and patient outreach, with a hopeful outlook for future production. The personal motivation behind the advocacy and the ongoing search for a manufacturing partner are detailed. The episode concludes with a call to action, emphasizing coordinated efforts and directing listeners to "Alliance to Protect Insulin Choice.org," along with sponsor messages and community information.

Keywords

Q&A

• What is the primary goal of the "Alliance to Protect Insulin Choice" organization?

  The primary goal is to ensure continued access to Levemir insulin by advocating for its production by a new manufacturer, or ideally, by Novo Nordisk continuing its production.

• Why is Levemir insulin particularly important for pregnant women?

  Levemir has a proven safety and efficacy profile in pregnancy, making it a preferred choice for managing gestational diabetes and type 2 diabetes during pregnancy to ensure optimal blood glucose control for both mother and baby.

• What challenges does a new manufacturer face in producing Levemir insulin after it's off-patent?

  A new manufacturer would need significant investment (estimated $200 million) and time (5-8 years) to prove biosimilarity to the FDA for a product no longer available, making assistance from the original manufacturer crucial.

• How has the approach to advocating for Levemir changed over the past two years?

  Initially, advocacy efforts were met with less receptiveness. Now, there's bipartisan congressional support, positive FDA engagement, and increasing physician and patient outreach, indicating growing momentum.

• What is the significance of engaging with congressional offices in the Levemir advocacy?

  Engaging with congressional offices is vital as it brings attention to the issue from influential figures, prompting action from regulatory bodies like the FDA and encouraging pharmaceutical companies to address the need for Levemir.

• Why can't other companies simply start making Levemir without Novo Nordisk's help?

  Producing a biosimilar requires access to specific drug ingredients and manufacturing knowledge, which Novo Nordisk possesses. Without their cooperation, replicating the exact formulation and navigating FDA approval is extremely difficult and time-consuming.

• What is the "Small Sips" series on the Juice Box Podcast?

  "Small Sips" is a series on the Juice Box Podcast featuring short, clear, and easy-to-understand explanations of diabetes management topics, designed to provide clarity without overwhelming listeners.

• What role do former Novo Nordisk drug representatives play in understanding Levemir's value?

  Older representatives who promoted Levemir before the focus shifted to Tresiba possess deep knowledge of its pharmacokinetic differences and value, making them valuable resources for understanding the insulin's importance.

Show Notes