FDA approves once-weekly insulin Awiqli for children with type 2 diabetes

The study

This is a regulatory announcement from the US Food and Drug Administration (FDA), not a published trial. The FDA has approved Awiqli (insulin icodec-abae) injection, a long-acting insulin analog. It is approved as an adjunct to diet and exercise to improve glycaemic control in patients aged 10 years and older with type 2 diabetes mellitus. It is given by subcutaneous injection once weekly.

The FDA states that Awiqli was approved for adults with type 2 diabetes earlier this year. It calls Awiqli the first once-weekly insulin approved for children with type 2 diabetes. The application received a priority review.

The paediatric evidence described is a single-dose study of the pharmacokinetic properties (blood levels) of Awiqli in 18 patients aged 10 years and older with type 2 diabetes.

What they found

The paediatric patients absorbed the first dose faster than adults. Pharmacometric modelling, a type of mathematical analysis, then showed that blood levels in children become similar to those in adults after the first few doses. On this basis, the FDA says Awiqli is expected to lower blood glucose in paediatric patients in a similar way as it does in adults.

The FDA describes the safety profile as similar to that of other insulin products. The most common adverse reactions are hypoglycaemia, hypersensitivity reactions, injection site reactions, lipodystrophy, pruritus, rash, oedema and weight gain. Hypoglycaemia is the most common. Severe hypoglycaemia can cause seizures, unconsciousness, life-threatening complications or death.

The label also carries warnings for medication errors and accidental overdose, hyperglycaemia, hypokalaemia, and fluid retention and heart failure when used with thiazolidinediones.

How much weight to give it

This is a regulatory decision, and the FDA's statement that Awiqli is expected to work in children rests on extrapolation. The only paediatric data described are blood levels from a single dose in 18 patients, plus modelling. Blood levels are a surrogate. The notice does not report any paediatric results for HbA1c, hypoglycaemia rates, weight, or longer-term safety. It also does not report how long children were followed or who funded the study.

So the approval shows that regulators accepted the pharmacokinetic and modelling case. It does not show, from this notice, how Awiqli performs in children over weeks or months of weekly use. The details sit in the full prescribing information and the underlying review, which are not part of this notice.

For your clinic

This notice describes a US decision. It says nothing about other countries. Do not assume the same indication or access elsewhere.

For doctors who treat young people with type 2 diabetes, the main practical points are safety points. Hypoglycaemia is the leading risk. Because Awiqli is dosed differently from other insulins, the FDA advises that patients check the product label and the dose shown on the FlexTouch pen before each injection. Teaching about dosing errors would matter in any programme that uses it. The thiazolidinedione warning is also relevant when reviewing a young patient's other medicines.

Read the full prescribing information, and any guideline advice, before forming a view on where a once-weekly insulin fits in paediatric care.