FDA Questions Safety of Once-Weekly Insulin for Type 1 Diabetes

Background on Once-Weekly Insulin

The FDA is currently reviewing a new insulin product called insulin icodec, developed by Novo Nordisk. This product is notable because it is intended to be taken once a week, unlike current insulin treatments that require daily administration.

This new insulin product aims to make diabetes management more convenient for patients. However, questions have arisen about its safety, particularly for adults with type 1 diabetes.

Key Concerns Raised by the FDA Committee

During a recent meeting, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee discussed the risks and benefits of insulin icodec. The primary concern was about the risk of hypoglycemia, a condition where blood sugar drops too low, which can be very dangerous.

Committee members pointed out that insulin icodec had a higher rate of severe hypoglycemia events compared to daily insulin options. For instance, in a clinical trial, the rate of hypoglycemic events was 19.9 events per patient per year for insulin icodec, compared to 10.4 events for the daily insulin degludec.

Clinical Trial Results and Analysis

The ONWARDS 6 trial was a key study in evaluating insulin icodec. It showed that while the new insulin was effective in controlling HbA1c levels (a measure of blood sugar control), it did not offer significant benefits over existing daily insulin options.

Moreover, the trial indicated that insulin icodec's peak glucose-lowering effect occurred on days 2 to 4 after the weekly injection, contributing to the higher risk of hypoglycemia during this period.

Mitigating Risks

Novo Nordisk proposed several strategies to reduce these risks, such as using a continuous glucose monitor (CGM) to keep better track of blood sugar levels. They also suggested starting the insulin only in patients with stable blood sugar levels.

However, many committee members felt that these suggestions were not enough. They called for stricter guidelines and additional clinical trials to further evaluate the insulin's safety for specific patient groups.

Potential Benefits and Populations

Despite the concerns, some experts believe that insulin icodec could benefit a select group of patients. For example, those who fear needles or have difficulty managing daily injections might find a weekly insulin more appealing.

Nonetheless, the committee stressed that it is up to Novo Nordisk to identify and test this subpopulation to confirm safety and effectiveness.

Final Thoughts from Experts

FDA advisors like Dr. Jill Crandall and Dr. Erica Brittain expressed that the balance between risks and benefits was not favorable for insulin icodec in its current form. They highlighted that while convenience is essential, safety cannot be compromised.

On the other hand, some members like Dr. Barbara Onumah voted in favor, suggesting that certain patients who cannot manage daily insulin could potentially benefit from this weekly option.

Next Steps

The FDA is not required to follow the advisory committee's recommendations, but they generally do. This means that Novo Nordisk might need to conduct further studies and provide more robust data to gain approval for insulin icodec.

Overall, while the concept of a once-weekly insulin is promising, ensuring its safety for all users remains a significant hurdle that needs to be addressed.