US FDA approves Novo Nordisk’s Ozempic 2 mg to treat type-II diabetes

Novo Nordisk yesterday announced that the US Food and Drug Administration (FDA) has approved a 2 mg dose of Ozempic (semaglutide) injection, a once-weekly Glucagon-Like Peptide-1 (GLP-1) analog indicated along with diet and exercise to improve blood sugar in adults with type-II diabetes, and to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type-II diabetes and known heart disease, Novo Nordisk informed via a statement.

Ozempic is not a weight loss drug, but may help people lose some weight. It will be available in three therapeutic doses (0.5 mg, 1 mg and 2 mg) to help people with type-II diabetes reach their blood sugar (A1C) goal, now including those with a higher A1C who have been unable to meet their A1C target, the statement said.

In the Ozempic Sustain phase-III clinical trial programme, up to 73 per cent of people with type-II diabetes treated with Ozempic 1 mg lowered their blood sugar and reached the American Diabetes Association target of <7%. Despite this, there are still people who are not at their blood sugar target. Ozempic 2 mg helps those who need additional glycemic control, and is an important option for patients and providers in the ongoing treatment of type-II diabetes, it added.

It also mentioned that in the Sustain Forte trial, people with an average starting A1C of 8.9 per cent treated with Ozempic 2 mg achieved a statistically significant and superior reduction in blood sugar of 2.1 per cent at week 40 compared to 1.9 per cent with Ozempic 1 mg (P<0.01). In the same study, people with an average starting weight of 219 lb treated with Ozempic 2 mg experienced a weight loss of 14.1 lb compared to a weight loss of 12.5 lb with Ozempic 1 mg; the difference was not statistically significant. For both doses of Ozempic, there were no new safety signals identified. The most common adverse events were gastrointestinal. Gastrointestinal adverse reactions occurred more frequently among patients receiving Ozempic 2 mg (34 per cent) vs Ozempic 1 mg (30.8 per cent).

The company expects to launch Ozempic 2 mg in the US shortly. It was approved by Swiss Medic in September 2021 followed by Health Canada and the European Medicines Agency (EMA) in January 2022, the statement concluded.