Zhitong Finance APP learned that the U.S. Food and Drug Administration (FDA) advisory teamthreecardMost members believe that Novo Nordisk (NVOthreecard.US) The benefits of weekly injections 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 monththreecard.US) ReportthreecardIt provided positive data from two phase III trials of its weekly insulin efsitora.
