New Insulin Treatment Sparks Safety Concerns at FDA 

United States: Among the most common diabetes treatments that most diabetes patients need are insulin therapies that involve injections done daily to maintain IAVL glucose levels. 

Nonetheless, a project that involves a weekly insulin injection is likely to attract the approval of the FDA, although a team made of staff advisors of the agency is still in doubt in terms of the efficiency of the new product in addressing some of the risks. 

FDA deliberation on Novo Nordisk  

In another development, during a Friday meeting, the Endocrinologic and Metabolic Drugs Advisory Committee, jointly with the FDA, discussed the risks and advantages of the weekly insulin icodec developed by Novo Nordisk. It will be an important addition to the existing diabetes medications because if approved by the agency, CNN Health noted that this will be one of the first weekly insulin products in the United States. 

The committee debate was based on two aspects: the safety and efficacy of insulin icodec in patients with type 1 diabetes. 

With regards to the question of whether Novo Nordisk has provided evidence that expanding the scope of representation of insulin icodec provides utility in improving glycemic control for adults with type 1 diabetes. 

Details of the advisory committee’s deliberations and votes will be disclosed and conveyed to the FDA for evaluation; while it is not obligatory to heed the advisory committee, the FDA considers the matter before deciding whether to approve the treatment. 

Clinical trials analysis 

In a comparative study of Phase 3 clinical trials, researchers reported that once weekly insulin codec was more effective in controlling high blood sugar than insulin degludec daily therapy but was accompanied by more cases of low blood sugar, hypoglycemia evidenced by loss of consciousness, and seizures. 

According to the committee’s meeting materials, “Insulin icodec was associated with 50 to 80 percent more clinically significant or severe hypoglycemia compared to insulin degludec at Week 52, depending on the method of analysis,” as CNN Health reported. 

Dr. Barbara Onumah, a committee member and an endocrinologist in Largo, Maryland, who voted yes on the benefits of insulin icodec outweighing its risks, said, “This would add a tool to the toolbox for clinicians.” 

She added, “It will not be beneficial for every person, but it might be useful for some persons,” and, “There’s still a few risk mitigation things that need to be ironed out clearly so that for the general provider or practitioner who would be writing this prescription, should it be approved, will be doing it correctly and safely – because safety would be very important.” 

Moreover, Dr. Matthew Drake, a committee member and an endocrinologist at Mayo Clinic in Rochester, Minnesota, who voted no, stated that his rationale behind his action was on the basis of comparing insulin icodec with the current gold standard of insulin degludec, “which has a good safety profile in my experience.”