Industry
FDA Approves Novo Nordisk's Weekly Insulin for Pediatric Use
The FDA has approved Novo Nordisk's Awiqli (insulin icodec-abae) as the first once-weekly, long-acting basal insulin for children ages 10 and older with Type 2 diabetes, according to the company's October 23 announcement. The drug cuts basal insulin injection frequency from seven times weekly to once, and is approved as an adjunct to diet and exercise. Approval relied on adult Type 2 diabetes studies, a pediatric pharmacokinetic study, and the ONWARDS clinical trial program. Awiqli is now available at more than 70,000 U.S. pharmacies.
Why it mattersState Medicaid pharmacy programs and MCOs will need to evaluate formulary placement, utilization management, and prior authorization criteria for a new high-cost pediatric insulin option that could shift prescribing patterns and drug spend.