The U.S. Food and Drug Administration today approved a new higher dose (7.2 mg) of Wegovy (semaglutide) injection, called Wegovy HD, for weight loss and long-term maintenance of weight loss for certain adult patients. The decision was granted just 54 days after filing and represented the fourth approval under the Commissioner’s National Priority Voucher (CNPV) pilot program.
“The new FDA is moving with unprecedented efficiency on products that advance national priorities,” said FDA Commissioner Martin Makary, M.D., M.P.H. “Today’s approval is another demonstration of what the FDA can accomplish when we try bold new things.”
Wegovy is a glucagon-like peptide-1 (GLP-1) receptor agonist. The new higher dose of Wegovy is indicated to reduce excess body weight and maintain weight reduction long-term in adults with obesity, or overweight with at least one weight-related condition. The approval of a new higher dose will provide adult patients with an additional therapeutic option offering the potential for greater weight loss.
The approval of Wegovy HD was supported by clinical data demonstrating that the higher dose resulted in additional average weight reduction compared to previously approved doses, with a safety profile consistent with the known side effects of semaglutide. In those with both obesity and type 2 diabetes, the higher dosage offered similar lowering of blood sugar (measured as hemoglobin A1C) compared to the lower dosage.
The most common adverse reactions observed were gastrointestinal, including nausea, vomiting, diarrhea, constipation, and abdominal pain. Reports of altered skin sensation (described as sensitivity, pain, or burning) were common, occurred more frequently at the higher Wegovy dosage than lower dosages, and generally resolved on its own (or with dose reduction). The FDA is currently conducting further investigations regarding this drug reaction.
Wegovy carries a boxed warning regarding the potential risk of thyroid C-cell tumors, based on findings in rodent studies. It should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. Health care professionals should counsel patients on appropriate use and monitor for adverse reactions.
The FDA granted the approval to Novo Nordisk.
The Commissioner’s National Priority Voucher pilot program seeks to expedite approval of applications that address critical national health priorities, such as bringing innovative therapies to the American people, addressing large unmet medical needs, promoting domestic manufacturing, and increasing affordability. A company selected for the program is issued a voucher entitling the company to benefits including enhanced communications and rolling review to allow for a shortened review time.
The FDA will hold a public hearing in June to solicit public feedback about the program. A Federal Register notice providing further information will be published soon
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