Novo Nordisk has been riding the momentum of weight loss drug Wegovy ever since it stormed onto the market in 2021, creating widespread hype and even some supply shortfalls. But, now, a cardio outcomes trial could seriously change the game for the burgeoning medicine.

In a large phase 3 trial, the drug cut the risk of major adverse cardiovascular events by 20% compared with placebo and standard of care, Novo said Tuesday. Specifically, investigators measured Wegovy's 2.4-mg dose for its ability to cut the risk of a cardio death, heart attack or stroke.
The trial enrolled 17,604 people and tested the drug for up to five years in people 45 and older who were overweight or obese and who had established cardiovascular disease. To be eligible for the trial, patients had to have had no history of diabetes.
Based on the trial win, Novo Nordisk said it expects to seek a label expansion to include the cardiovascular risk-reduction data in the U.S. and Europe yet this year. The company said the detailed results from the study, dubbed SELECT, will be presented at an upcoming scientific conference.
Investigators conducted the trial in 41 countries at more than 800 sites. The trial kicked off in 2018.
Analysts immediately shared enthusiasm about the results. In a note to clients, Wolfe Research's Tim Anderson, M.D., noted the readout is "a clear win not only for Novo, but also for [Eli Lilly] and the obesity category at large."
Eli Lilly is angling for an eventual obesity nod on its Type 2 diabetes med tirzepatide, also known as Mounjaro.
Anderson went on to suggest that Novo's results were "essentially a best-case scenario."
Adding to the hype, analysts at Intron Health opined that Medicare is "almost certain" to allow reimbursement of obesity drugs following the readout.
Further, the analysts believe the CV data could "potentially protect" Wegovy from higher efficacy therapies such as Mounjaro from Eli Lilly, which doesn't expect to complete its own cardio outcomes study until 2027.
Still, manufacturing will continue to plague Wegovy's rollout, according to the Intron team. While suggesting active pharmaceutical ingredients shouldn't be a problem, they said they expect fill-and-finish capacity to continue being a thorn in Novo's side.
Specifically, the team expects drug shortages to persist for the next two to three years, which will necessarily trigger a phased rollout outside of the U.S.
Since its debut in 2021, demand for Wegovy has been so high that Novo has at times struggled to supply it. Back in early May, Novo said it would reduce U.S. supply of lower dosage strengths to “safeguard continuity of care."
Several weeks later, the company said it was pausing some key Wegovy promotional efforts "to avoid stimulating further demand."
This included all local television advertising, with Novo also postponing planned national television advertising for Wegovy.

Reference: https://www.fiercepharma.com/pharma/novo-nordisk-touts-cardio-outcomes-win-star-obesity-drug-wegovy