Clinical Novo’s Wegovy Successful in Reducing Risk of Cardiovascular Events...

Novo’s Wegovy Successful in Reducing Risk of Cardiovascular Events in Phase 3 Trial

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In a large Phase 3 trial that enrolled over 17,600 participants aged 45 and older, Novo Nordisk’s Wegovy was found to reduce the risk of major adverse cardiovascular events by 20% compared to the usual standard of care and placebo.

Participants in the trial were given a 2.4 mg dose of the drug for up to 5 years to test whether the drug was successful in cutting the risk of adverse cardiovascular events such as heart attacks, strokes, or cardio-related deaths.

The trial kickstarted in 2018 and spanned approximately 800 sites in 41 countries. To be eligible to participate in the trial, participants had to suffer from obesity, be overweight, and have an established history of cardiovascular disease. Additionally, participants were required to have no history of diabetes.

The company expects to share detailed results of the Phase 3 trial at an upcoming medical conference, and the positive trial results have also encouraged the company to apply for a label expansion to include the cardiovascular risk-reduction data in Europe and the U.S. later this year.

According to Tim Anderson of Wolfe Research, these positive results aren’t just good news for Novo, but also for other biotechs working in the obesity category. For instance, Eli Lilly aims to eventually secure an obesity approval for its Type 2 diabetes drug tirzepatide, also known as Mounjaro.

Despite this, analysts are certain that Wegovy is protected from the threat of other high-efficacy therapies like Lilly’s because Lilly is not likely to submit its cardio outcomes before 2027.

Analysts have also shared the excitement around the drug. In fact, analysts from Intron Health have stated that there is little to no doubt that after the results are made public, Medicare will allow the reimbursement of obesity drugs.

The only challenge facing the drug comes from issues with the rollout. Since the drug first came out in 2021, it gained increased popularity as a weight-loss drug, which has often led to supply issues. While Intron analysts expect there to be no issue with active pharmaceuticals, the fill-and-finish capacity may continue to raise concerns for Novo.

To protect the continuity of care, the company was already forced to reduce the supply of lower dosage strengths in the U.S., and drug shortages are expected to persist for the next two to three years. As a result, the country may experience a phased rollout of the drug.

The situation has at times been so dire that Novo has been forced to halt key promotional events to prevent excess demand for the drug. Currently, all local television advertising and national television advertising for Wegovy have been put on hold.

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