Novo Nordisk receives FDA approval of higher-dose Ozempic

Oksana Yakoff, a diabetes educator, working with a patient at the Diabetes Center at Holy Name Medical Center. (Holy Name Medical Center)

Plainsboro-based Novo Nordisk on Monday said the U.S. Food and Drug Administration approved a higher dosage of 2 mg of Ozempic for the treatment of adults with type 2 diabetes.

Ozempic is now approved in the U.S. in doses of 0.5 mg, 1 mg and 2 mg, the company said.

The once-weekly glucagon-like peptide-1 analog injection indicated along with diet and exercise to improve blood sugar in adults with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease.

It is prescribed to help people with type 2 diabetes reach their blood sugar, or A1C, goal, now including those with a higher A1C who have been unable to meet their A1C target.

Novo Nordisk expects to launch Ozempic 2 mg in the U.s. in the second quarter of 2022. Ozempic 2 mg is now approved in the U.S., the EU, Canada and Switzerland.