The FDA has expanded approval of Awiqli, Novo Nordisk's once-weekly basal insulin, to children 10 and older with type 2 diabetes. For those patients, one weekly shot replaces seven daily injections of long-acting insulin. Novo Nordisk announced the approval on October 23, about seven months after the drug was cleared for adults.
The decision rests mainly on adult clinical trials. The only study in young people was a single-dose study in 18 children and teens, according to AJMC's report on the approval. That study measured how the drug moved through the body, not whether it lowered blood sugar over months.
