{"id":2091,"date":"2024-05-27T15:13:00","date_gmt":"2024-05-27T15:13:00","guid":{"rendered":"https:\/\/healthyretirementnews.com\/index.php\/2024\/05\/27\/fda-advisers-weigh-benefits-of-weekly-insulin-for-people-with-diabetes\/"},"modified":"2024-05-27T15:13:00","modified_gmt":"2024-05-27T15:13:00","slug":"fda-advisers-weigh-benefits-of-weekly-insulin-for-people-with-diabetes","status":"publish","type":"post","link":"https:\/\/healthyretirementnews.com\/index.php\/2024\/05\/27\/fda-advisers-weigh-benefits-of-weekly-insulin-for-people-with-diabetes\/","title":{"rendered":"FDA advisers weigh benefits of weekly insulin for people with diabetes"},"content":{"rendered":"
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Most types of insulin therapy, an important part of diabetes treatment for many people, are given as daily injections to help manage blood sugar levels. Now, the maker of a once-weekly insulin injection is seeking approval from the US Food and Drug Administration, but a committee of agency advisers is divided on whether the benefits of the product may outweigh the risks. <\/p>\n

In a meeting Friday, the FDA\u2019s Endocrinologic and Metabolic Drugs Advisory Committee weighed whether the benefits of Novo Nordisk\u2019s weekly product, called insulin icodec, outweigh its risks. If the agency signs off, the treatment will be the first weekly insulin available in the United States. <\/p>\n

The committee\u2019s discussions focused on the safety and efficacy of insulin icodec, specifically in people with type 1 diabetes. The advisers were asked to answer a question of, based on the available data, whether Novo Nordisk has demonstrated that the benefits of insulin icodec outweigh its risks for improving glycemic control in adults with type 1 diabetes. Four voted yes. Seven voted no. <\/p>\n

The advisory committee\u2019s discussions and voting outcomes will be shared with the FDA, which takes into consideration but does not have to follow the committee\u2019s advice when deciding whether to approve the <\/strong>treatment. <\/p>\n

An analysis of Phase 3 clinical trials found that once-weekly insulin icodec was better at reducing high blood glucose levels in comparison with the once-daily therapy insulin degludec, but insulin icodec was associated with a higher incidence of hypoglycemia, also known as low blood glucose, which can lead to a loss of consciousness or seizures. <\/p>\n

\u201cInsulin icodec was associated with 50 to 80% more clinically significant or severe hypoglycemia compared to insulin degludec at Week 52, depending on the method of analysis,\u201d the committee\u2019s meeting materials say. <\/p>\n

If the product is approved by the FDA, some panel members said, there should be guidance on ways to mitigate and treat the risk of hypoglycemia. <\/p>\n

Committee member Dr. Barbara Onumah, a endocrinology in Largo, Maryland, voted yes on the benefits of insulin icodec outweighing its risks. <\/p>\n

\u201cThis would add a tool to the toolbox for clinicians,\u201d Onumah said. <\/p>\n

\u201cIt will not be beneficial for every person, but it might be useful for some persons,\u201d she said. \u201cThere\u2019s 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 \u2013 because safety would be very important.\u201d <\/p>\n

Committee member Dr. Matthew Drake, an endocrinologist at Mayo Clinic in Rochester, Minnesota, voted no. <\/p>\n

Drake said his rationale was based on comparing insulin icodec with the current gold standard of insulin degludec, \u201cwhich has a good safety profile in my experience,\u201d he said. <\/p>\n

Committee member Erica Brittain also voted no but called it a hard decision. <\/p>\n

\u201cI agree that there\u2019s theoretical benefits, and anyone could understand wanting to have fewer injections, and that\u2019s very important,\u201d said Brittain, a biostatistician at the National Institutes of Health. <\/p>\n

\u201cUnfortunately, within the trial data, we don\u2019t see the benefit of better glycemic control, which I think was promised in terms of adherence. I understand that that would be hard to show in this clinical trial population, but things kind of go the other way,\u201d she said. <\/p>\n

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      The committee also discussed how a weekly insulin injection might be an easier treatment regimen to follow than daily injections. <\/p>\n

      Studies suggest that about 53% of adults with type 1 diabetes adhere to existing insulin therapy schedules, \u201cwith approximately 22% of patients missing at least one basal insulin dose over any 14-day period,\u201d according to the FDA advisory committee\u2019s meeting materials. \u201cNonadherence to insulin therapy is a precipitating factor for diabetic complications such as diabetic ketoacidosis.\u201d <\/p>\n

      Novo Nordisk isn\u2019t the only company developing a weekly insulin therapy for diabetes patients. Last week, Eli Lilly announced that its once-weekly insulin efsitora alfa was \u201cequally safe and effective\u201d in Phase 3 trials involving adults with type 2 diabetes using insulin for the first time and those who require multiple daily insulin injections. However, Lilly has not yet requested FDA approval. <\/p>\n<\/p>\n

      This post appeared first on cnn.com<\/div>\n<\/div>\n

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