Novo's Ozempic gains MACE risk reduction label in US

Novo Nordisk

Novo Nordisk’s Ozempic (semaglutide) weekly GLP-1 injection has gained a new US indication after the FDA agreed a label extension to cover reducing the risk of cardiac events in adults with type 2 diabetes and known heart disease.

This is the latest development in the ongoing battle between the Danish pharma and Eli Lilly for the GLP-1 market – the big US pharma markets a rival weekly drug from the same class, Trulicity (dulaglutide).

Cardiovascular disease (CVD) is the main cause of death and disability among people with type 2 diabetes and adults with the disease are two to four times more likely to develop CVD than adults without diabetes.

The extended use covers reduction of risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults with type 2 diabetes and known heart disease.

Novo began to build a case with the FDA to get the sought-after CV risk reduction indication based on strong results from the two-year SUSTAIN 6 outcomes trial, published last year.

Although the trial involving 3,297 patients with diabetes and established heart disease did not provide a direct comparison with Trulicity, the MACE reduction of 26% compared with placebo seen in SUSTAIN 6 was more convincing than the 12% improvement over placebo seen with Trulicity in the rival REWIND trial.

Regulators in the US and Europe are currently reviewing Eli Lilly’s CV data.

In a separate development US prescribing information for Rybelsus, a daily pill formulation of semaglutide, has been updated to include an analysis from the primary endpoint of the PIONEER 6 cardiovascular outcome trial.

These data showing the drug's cardiovascular safety, are based on a measurement of three-component MACE, with further data due in the coming years.

In June 2019, Novo began the SOUL trial in 9,642 adults with type 2 diabetes and established cardiovascular disease to further evaluate the cardiovascular effect of Rybelsus.

The trial is investigating the effects of Rybelsus on the incidence of MACE vs. placebo in addition to standard of care.