Novo Nordisk has just taken two big steps toward cementing its lead in the weight loss treatment market. Late last week, the FDA approved a new label expansion for Wegovy (semaglutide), and just before that the company released promising early trial results for its experimental weight loss pill, amycretin. Patients on the new pill lost about 13.1% of their weight after 12 weeks, which surpasses the six percent weight loss seen in those who took Wegovy for the same time period.
Novo and Eli Lilly are currently the leaders in the relatively new, and booming, GLP-1 agonist market, which comprises drugs that suppress appetite by signaling the pancreas to produce insulin and thus cause digestion to slow. Amycretin also works through GLP-1, but in addition targets the pancreas hormone amylin, which affects hunger. The market for these drugs is already estimated at $5B but is expected to climb dramatically. Additional entrants are also expected.
The new Wegovy approval is based on a supplemental New Drug Application for reducing risks of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke in adults with either overweight or obesity and established cardiovascular disease (CVD).
The SELECT cardiovascular outcomes trial demonstrated that Wegovy significantly reduced the risk of MACE by 20% compared to placebo when added to standard of care. The exact mechanism of cardiovascular risk reduction has not been established.
Findings from SELECT also showed that over a period of up to five years, risk reductions in MACE were achieved regardless of baseline age, sex, race, ethnicity, body mass index (BMI) and level of renal function impairment. In addition, the label is updated to include data from SELECT showing a risk reduction in cardiovascular death by 15% and a risk reduction of death from any cause by 19%, both compared to placebo.
“We are very pleased that Wegovy is now approved in the U.S. as the first therapy to help people manage their weight and reduce cardiovascular risks,” said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk. “This approval is an important milestone for people living with obesity and cardiovascular disease, as the SELECT data demonstrated that Wegovy has the potential to prolong lives by addressing some of the leading causes of preventable deaths by reducing the risks of cardiovascular events.”
Novo Nordisk has also filed for a label expansion in the EU, and a decision is expected in 2024.
The primary objective of the SELECT trial was to demonstrate the superiority of semaglutide 2.4 mg compared to placebo with respect to reducing the incidence of three-point MACE consisting of cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke. The trial enrolled 17,604 adults and was conducted in 41 countries at more than 800 investigator sites. SELECT was initiated in 2018.
The SELECT data were presented at the American Heart Association (AHA) annual meeting in November 2023 and published in the New England Journal of Medicine (NEJM).
In the U.S., Wegovy is now indicated to reduce the risk of MACE in adults with established cardiovascular disease and either obesity or overweight, as well as to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with obesity and in adults with overweight in the presence of at least one weight-related comorbid condition.
