Saturday, April 20, 2024

Wegovy Receives FDA Approval for Cardiovascular Events Reduction

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Following a supplemental New Drug Application (sNDA) submitted by Novo Nordisk, the U.S. FDA has approved an expanded label for Wegovy reducing the risks of cardiovascular events. The treatment is now indicated for reducing risks of major adverse cardiovascular events (MACE), including cardiovascular mortality, non-fatal heart attack or myocardial infarction, and non-fatal stroke.

The endorsement for the new indication is based on the results from the SELECT cardiovascular outcomes clinical trial. Conducted as a randomized, double-blind, parallel-group, placebo-controlled study, it was initiated in 2018 with 17,604 adults from 41 countries to assess the efficacy of semaglutide 2.4mg versus placebo for MACE prevention.

Wegovy’s Breakthrough in Reducing Cardiovascular Events: Promising Results from a Five-Year Trial

All participants in the trial were aged 45 years or above, with a body mass index (BMI) of 27 kg/m2 or higher, and without a history of diabetes. They were observed over five years. The trial’s findings indicated that Wegovy significantly reduced the MACE risk by 20% when used along with standard care, compared to placebo. Moreover, the reduction in MACE risk was consistent across various subgroups, including age, sex, race, ethnicity, BMI, and the level of renal function impairment.

Furthermore, the updated label for Wegovy includes findings demonstrating a 15% decline in cardiovascular mortality and a 19% reduction in mortality from any cause, both versus placebo. Novo Nordisk also seeks label expansion for the treatment in the European Union, with a decision anticipated this year.

Cardiovascular Events

A New Era in Combating Cardiovascular Risks and Obesity

Novo Nordisk Development head and executive vice-president Martin Holst Lange expressed satisfaction at the development, highlighting Wegovy’s potential to prolong lives by addressing some of the leading causes of preventable deaths by reducing the risks of cardiovascular events.

In summary, the FDA’s approval for the expanded label for Wegovy, based on the results of the SELECT cardiovascular outcomes clinical trial, indicates the drug’s significant potential in reducing MACE risks. This is a significant milestone, as it is the first therapy approved to manage weight and reduce cardiovascular risks. The consistent reduction in MACE risk across various demographic subgroups, along with a demonstrable decrease in cardiovascular mortality, further underscores the importance of this development.

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