Novo Nordisk's Once-Weekly Insulin Icodec Fails to Gain FDA Advisory Committee Support Over Safety Concerns

The majority of members of the U.S. Food and Drug Administration (FDA) advisory panel believe that the benefits of Novo Nordisk's (NVO.US) once-weekly insulin icodec do not outweigh the risks.

Of the 11 voting members at the Endocrinologic and Metabolic Drugs Advisory Committee meeting, seven disagreed that the benefits outweighed the risks, while four agreed.

Briefing documents from FDA scientists showed that in a pivotal trial, the once-weekly insulin icodec had hypoglycemia issues compared to Novo Nordisk's once-daily Tresiba (insulin degludec). Several members of the expert panel expressed concerns about this.

Novo Nordisk mentioned that using a blood glucose monitoring device when prescribing the drug is one way to reduce the risk of hypoglycemia.

Several members indicated that insulin icodec may be suitable for some patients, but Novo Nordisk needs to specify which patient groups these are.

Notably, earlier this month, Novo Nordisk's competitor Eli Lilly (LLY.US) reported positive data from two Phase III trials of its once-weekly insulin efsitora.

Editor: Yu Jian SF069