Federal regulators have given the green light to a new higher-dose version of the widely used obesity treatment, Wegovy, developed by the Danish pharmaceutical company Novo Nordisk. The U.S. Food and Drug Administration (FDA) has approved a 7.2-milligram dose of semaglutide, which is expected to help users achieve greater weight loss and maintain their results more effectively. Previously, the highest approved dosage was 2.4 milligrams, administered through weekly injections.
The FDA’s expedited review process allowed for swift approval of the new dosage, completing the review just 54 days after its request was acknowledged. This higher-dose formulation is slated to be available at pharmacies across the United States starting in April, although the pricing details have yet to be disclosed.
In February, European regulatory authorities had already authorized the higher dose, labeled Wegovy HD, which demonstrated promising results in clinical studies. Participants in these studies achieved an average weight loss of approximately 19%—equating to nearly 47 pounds—over a span of 17 months, in contrast to a 16% loss (or about 39 pounds) associated with the previously approved lower dose.
The development of the higher dose addresses the needs of patients who have not reached their desired therapeutic goals with the 2.4-milligram shot. A study published in the journal Lancet Diabetes & Endocrinology revealed that a significant number of individuals either struggle with weight loss or fail to meet their personal objectives at the existing lower dosage.
Additionally, the FDA recently approved an oral version of Wegovy, consisting of 25 milligrams of semaglutide, designed to ensure adequate absorption through the digestive system.
Dr. Jody Dushay, an endocrinologist and obesity specialist from Harvard Medical School, expressed optimism regarding the new higher-dose product. She believes it could be particularly beneficial for patients who tolerate the lower-dose version but have not achieved significant weight loss. The higher dose may also serve as an alternative for those who do not respond adequately to the highest dose of a competing obesity drug from Eli Lilly, known as Zepbound.
Despite the potential advantages, the clinical trials indicated that some side effects, including nausea, vomiting, and constipation, were reported by over 70% of participants taking the higher 7.2-milligram dosage, compared to more than 60% of those on the lower dose and approximately 43% of those receiving a placebo. Furthermore, around 23% of individuals using the higher dose experienced a condition characterized by painful skin sensations, compared to just 6% in the lower-dose group and less than 1% in placebo participants.
Serious adverse events were recorded in nearly 7% of the participants on the 7.2-milligram dose, compared to about 11% in the lower-dose group and around 5% among those treated with a placebo. Dr. Dushay highlighted the significant leap in dosage, noting that an intermediate step may have been beneficial. She emphasized that real-world data will be crucial in determining whether side effects observed in clinical trials translate to broader populations.
The development of Wegovy and its new higher dosage signifies a major step forward in the ongoing battle against obesity, offering hope to many individuals looking for effective weight loss solutions.
