3dstrippoker| Novo Nordisk's weekly insulin icodec is not approved by most FDA advisers
U.S. Food and Drug Administration (FDA) Advisory Panel3dstrippokerMost members believe that Novo Nordisk (NVO3dstrippoker.US) Inject once a week3dstrippokerThe benefits of insulin icodec do not outweigh the risks.
Of the 11 voting members at the Endocrinology and Metabolism Drugs Advisory Committee meeting, 7 disagreed that the benefits outweigh the risks, while 4 agreed.
Briefing documents provided by FDA scientists showed that in a pivotal trial, weekly insulin icodec was associated with hypoglycemia compared to Novo Nordisk's daily injection of Tresiba(insulin degludec). Several expert group members expressed concern about this.
Novo Nordisk mentioned that using blood sugar monitoring equipment when prescribing the drug is a way to reduce the risk of hypoglycemia.
Several members said that insulin icodec may be suitable for some patients, but Novo Nordisk needs to clarify which groups these patients belong to.
It is worth mentioning that Novo Nordisk competitor Lilly earlier this month3dstrippoker.US) reported positive data from two phase III trials of its weekly injection of insulin efsitora.
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