Most members of the FDA advisory panel believe that the benefits of Novo Nordisk (NVO.US) insulin icodec injections once a week do not outweigh the risks.
The Zhitong Finance App learned that most members of the US Food and Drug Administration (FDA) advisory panel believe that the benefits of Novo Nordisk (NVO.US) insulin icodec injections once a week do not outweigh the risks.
Of the 11 voting members of the Advisory Committee on Endocrine and Metabolic Drugs, 7 members disagreed that the benefits outweighed the disadvantages, while 4 agreed.
Briefing documents provided by FDA scientists showed that in a key trial, weekly insulin Icodec injections had low blood sugar problems compared to Novo Nordisk's daily Tresiba (insulin degludec) injections. Several panellists expressed concern about this.
Novo Nordisk mentioned that using a blood sugar monitoring device 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 clearly state who these patients are.
It's worth mentioning that earlier this month, Novo Nordisk competitor Lily.US (LLY.US) reported positive data from two phase 3 trials of its weekly insulin efsitora injections.