By Nikolaj Skydsgaard and Jacob Gronholt-Pedersen
COPENHAGEN (Reuters) – Novo Nordisk hopes to show additional health benefits from taking its hugely popular drug Wegovy, apart from losing weight and cutting the risk of heart disease, its drug development executive told Reuters on Thursday.
The Danish drugmaker this week published headline results from its major SELECT trial, which showed that the weekly injection decreased the risk of heart attacks and strokes by 20%.
The company said it will seek regulatory approval to have the cardiovascular benefit added to the drug’s label. Wegovy can help patients to shed 15% of their weight alongside diet and exercise changes.
Further analysis of the results from the five-year trial, which included more than 17,000 patients, may also reveal more health benefits in areas such as kidney disease, heart failure and risk of hospitalisation.
“We are looking at a wide number of co-morbidities to obesity,” executive vice president of development Martin Holst Lange told Reuters, referring to other diseases that may be associated with being overweight.
Showing a medical benefit is a big boost for Novo’s hopes of moving Wegovy beyond its image as a lifestyle drug. The data may help persuade insurers in the United States and cost-conscious health authorities in Europe to cover its cost for a wider range of patients. It costs $1,300 a month in the U.S..
Novo on Thursday hiked its full-year outlook on the back of better-than-expected sales of its highly-effective diabetes and obesity drugs Ozempic and Wegovy, which are based on the same active ingredient, semaglutide.
“We’ll also look at all-cause mortality. We’ll look at heart failure. We’ll look at kidney disease. And we’ll also look at […] risk of hospitalisation, days in hospital,” Lange said.
Semaglutide already helps lower blood pressure, cholesterol and inflammation, Lange said, creating a “holistic picture of the benefits that we potentially see with semaglutide”.
The trial results will most likely be presented at the American Heart Association conference in Philadelphia in November, Lange added.
Novo will also follow participants from the SELECT trial for years to come to investigate whether patients, that have been treated with Wegovy, have a lower risk of developing diabetes after ending treatment.
“If we see data to suggest that patients on semaglutide have had […] a lower risk of developing diabetes than patients on placebo, then we can have a dialogue with the regulatory authorities if those data are sufficient to give a claim on delay of diabetes,” Lange said.
(Reporting by Nikolaj Skydsgaard; Editing by Josephine Mason, Kirsten Donovan)
