FDA Evaluates Safety Concerns of Weekly Insulin for Type 1 Diabetes

FDA Committee Questions Safety of Once-Weekly Insulin

Recently, a special committee formed by the U.S. Food and Drug Administration (FDA) expressed concerns about the safety of a new, experimental insulin product that would be used just once a week for people with type 1 diabetes.

This committee, known as the Endocrinologic and Metabolic Drugs Advisory Committee, voted 7-4 against recommending the approval of Novo Nordisk's long-acting insulin icodec. The main concern was the increased risk of severe hypoglycemia, or dangerously low blood sugar levels, among users.

Understanding the Risks and Benefits

Despite some benefits, the committee felt that the risks outweigh potential advantages. Dr. Jill Crandall from Albert Einstein College of Medicine stated that the benefits were not clear enough to justify the risks. Echoing this sentiment, Dr. Erica Brittain from the National Institutes of Health pointed out that the trial data did not show any significant benefit compared to existing daily insulin treatments.

During a study known as the ONWARDS 6 trial, the once-weekly insulin did not prove to be superior to a once-daily option, specifically degludec, in reducing HbA1c levels. Moreover, the frequency of severe hypoglycemic events was almost double for those using the weekly insulin compared to the daily one.

Potential for Targeted Use

While some members saw a limited potential for this insulin, they stressed careful use and additional safety measures. For example, using the product in conjunction with continuous glucose monitoring (CGM) devices might help mitigate risks.

Other suggestions included restricting its usage to those with well-controlled blood sugar levels prior to starting the treatment, or excluding patients with a history of hypoglycemia. Such precautions could help identify those who might benefit without the higher associated risks.

Additional Safeguards and Recommendations

The committee proposed other safety measures like prescribing the insulin for use mainly over weekends when people often consume more food and have higher blood sugar levels. However, some experts like Dr. Paul Beringer from the University of Southern California remained skeptical, considering these strategies unproven and challenging to put into practice.

Identifying the Right Candidates

Another point raised was the need for more targeted trials. The idea was that further tests could help identify specific groups who might benefit from weekly dosing. This group might include patients afraid of daily injections or those struggling to control their blood sugar with daily insulin.

Dr. Matthew Drake from the Mayo Clinic pointed out that the patients most likely to benefit might also be the ones less focused on frequent blood sugar monitoring, making it tough to manage the risks effectively.

Final Considerations

Ultimately, although some committee members like Dr. Barbara Onumah supported the novel insulin, thinking it would benefit a subgroup of patients with poor glycemic control, the consensus leaned towards requiring more stringent trials before approval.

While the FDA typically adheres to the recommendations made by its advisory committees, it is not an absolute requirement, meaning the decision for approval might still see further deliberation.