For Novo Nordisk to gain approval in the U.S. for its groundbreaking Awiqli (insulin icodec), it will have to first pass muster with a panel of experts next month, according (PDF) to a notice in the Federal Register.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on May 24 to consider Novo’s application for the injected basal insulin analogue which, if approved, would give Type 1 and Type 2 diabetes patients a once-weekly option. In announcing the review, the FDA has asked for public comment on Awiqli.
The announcement comes after Novo revealed in February that the FDA needed an additional three months to review the application, pushing an April target decision date into the third quarter. The company said that the delay was necessary because of changes it made to its application.
The company is mum on whether it was surprised that the FDA is calling for the adcomm. Novo also stopped short of revealing what information the regulator is seeking.
"We look forward to participating in these discussions with the committee and are confident in the potential of once-weekly basal insulin icodec to help manage diabetes for people who require insulin," Novo said.
Last month, the Europe Medicines Agency’s Committee for Medicinal Products for Human Use recommended Awiqli for approval. Novo expects an official approval from the European Commission to come in late May.
In an interview with Fierce Pharma three years ago, Novo CEO Lars Fruergaard Jorgensen called the treatment a “revolution” in the field, adding that “the world has never seen a weekly insulin.”
Novo is seeking approval for Awiqli after conducting six phase 3 studies which included more than 4,000 patients. In people with Type 2 diabetes, Awiqli achieved superior blood sugar reduction and time spent within a recommended blood sugar range compared with daily basal insulin.
In those with Type 2 diabetes who have not been treated with insulin, observed rates of hypoglycemia were below one event per year with both Awiqli and the comparators. In people with Type 1 diabetes, Awiqli showed non-inferiority to the company’s daily insulin in reducing blood sugar but with a higher estimated rate of hypoglycemia compared with daily insulin.
Novo’s attempts to advance its insulin program come as the company is thriving behind its blood-sugar modification treatments for Type 2 diabetes and obesity. The company had a year-over-year sales increase of 31% in 2023, from 177 billion Danish kroner ($25.1 billion) to 232.3 billion Danish kroner ($33.7 billion).
Fueling the surge were sales of Ozempic, which increased 60% to 95.7 billion Danish kroner ($13.9 billion) and Wegovy, which reached 9.6 billion Danish kroner ($4.5 billion) in its second full year on the market.