FDA approves Onswik once-weekly insulin for type 2 diabetes

The US Food and Drug Administration (FDA) has approved Onswik (insulin efsitora alfa-gobe), a long-acting insulin designed for once-weekly administration, for use in adults with type 2 diabetes alongside diet and exercise.

Clinical data from four Phase 3 QWINT trials involving over 3,400 adults demonstrated that Onswik is noninferior to daily insulin glargine or insulin degludec in reducing A1C levels. While providing the convenience of weekly dosing, the treatment was not found to be more effective than daily insulin. Notably, Onswik is not recommended for individuals with type 1 diabetes due to an increased risk of severe hypoglycemia, and its safety and efficacy in children have not been established.

Onswik is the second weekly basal insulin to receive FDA approval in the United States, following Novo Nordisk’s Awiqli. Other recent regulatory developments include the FDA granting Priority Review to Insmed’s application for amikacin liposome inhalation suspension (Arikayce) for MAC lung disease, and the approval of obinutuzumab (Gazyva) for certain pediatric and adult patients with idiopathic nephrotic syndrome.