Federal regulators have approved a new, higher-dose version of the obesity drug Wegovy, increasing the dosage from 2.4 milligrams to 7.2 milligrams. This approval by the FDA, which was expedited under the Very Rapid Drug Review Program, came just 54 days after the request was accepted. The new dosage is expected to be available in U.S. pharmacies by April, with pricing details to be released at that time.
Clinical studies indicated that the higher dose of Wegovy, now termed Wegovy HD, could lead to an approximate 19% weight loss (about 47 pounds) over 17 months, compared to a 16% loss (about 39 pounds) with the lower dose. While the lower dose proved effective, some patients did not reach their weight loss goals, prompting the need for higher doses.
Dr. Jodi Duchey, an endocrinologist, noted the potential benefits for users who responded poorly to lower doses. However, the higher dose also comes with increased side effects; over 70% of users reported issues such as nausea, vomiting, and constipation, compared to about 60% for the lower dose. Serious adverse events were observed in around 7% of those taking the 7.2-milligram dose. Dr. Duchey emphasized the importance of monitoring real-world side effects as the higher dose becomes available.
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