Insulin has meant a daily needle for children with type 2 diabetes for as long as doctors have prescribed it to them. For some US patients, that routine can now shrink. Adults received the same clearance earlier in the year. The pediatric extension went through priority review and rests on adult trials plus a single-dose study showing children's blood levels of the drug settle near adult levels after the first few doses, according to the FDA.
The disease was once unusual in young people. Rising childhood obesity has changed that, and pediatric specialists describe a course that often advances faster than in adults. A modeling study cited by Novo projects that nearly 84,000 people aged 19 and under will have type 2 diabetes by 2050, the release said. Teenagers are notoriously hard to keep on daily regimens, which is the gap the weekly shot aims to fill. The weekly shot comes with cautions of its own. Its dosage differs from that of other injectable diabetes medicines, and patients are told to check the pen's label before each injection to avoid mix-ups.
For Novo, the approval arrives in a strained year. The Danish company built itself on insulin long before Ozempic and Wegovy made it a household name. Those GLP-1 products now face pricing pressure and rivals. Management expects US sales to fall in 2026, citing injectable GLP-1 prescription trends, intensifying competition and lower realized prices, according to its second-quarter call. When the adult approval came in March, Novo called Awiqli the first once-weekly basal insulin cleared by the FDA and said it expected to launch the insulin in the US in the second half of 2026, Reuters reported, and the updated prescribing information now extends that US label to pediatric patients 10 and older.