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The U.S. Food and Drug Administration announced on Thursday its approval of a new, higher-dose Wegovy (semaglutide) injection.
The 7.2 mg dosage, called Wegovy HD, is intended for weight loss and long-term weight loss maintenance for adult patients. It is triple the previous maximum dose of 2.4 mg.
This marks the fourth approval in the FDA’s National Priority Voucher pilot program, which “seeks to expedite approval of applications that address critical national health priorities,” according to FDA Commissioner Dr. Martin Makary.
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“The new FDA is moving with unprecedented efficiency on products that advance national priorities,” he said in a press release. “Today’s approval is another demonstration of what the FDA can accomplish when we try bold new things.”
The higher-dose GLP-1 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,” per the FDA’s statement.
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“The approval of a new higher dose will provide adult patients with an additional therapeutic option, offering the potential for greater weight loss,” the agency stated.
The FDA’s approval, granted to drugmaker Novo Nordisk, was supported by clinical data that found higher doses resulted in additional average weight reduction compared to previous dosing.
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Higher-dose patients with both obesity and type 2 diabetes saw similar lowering of blood sugar compared to the lower dose, the agency noted.
The safety profile is consistent with the known side effects of semaglutide, which commonly include gastrointestinal reactions like nausea, vomiting, diarrhea, constipation and abdominal pain.
Skin sensitivity, pain or burning occurred more frequently with higher doses of Wegovy, but generally resolved on their own or with dose reduction, the FDA reported. The agency is investigating these adverse effects.
The FDA warned that Wegovy should not be used by patients with a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer) or who have multiple endocrine neoplasia syndrome type 2 (a rare inherited genetic disorder that causes tumors to develop in certain hormone-producing glands). All patients should see a doctor for guidance on proper use.
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Jamey Millar, executive vice president of U.S. operations for Novo Nordisk, commented on this approval in a press release.
“We are excited to bring Wegovy HD injection to adults with obesity who are looking for powerful weight loss, as no other weight-loss medicine has been studied to show superiority to Wegovy HD,” he said.
Millar also noted that Wegovy has been shown to reduce the risk of events such as stroke, heart attack or cardiovascular death in those who also have known heart disease.
Dr. Peter Balazs, a hormone and weight-loss specialist practicing in New York and New Jersey, reflected on results of the STEP UP clinical trial, on which the drug’s approval was based.
Patients taking the higher dose experienced an average weight loss of 20.7% compared to about 16% on the standard dose, the doctor noted. About one-third lost 25% or more of their body weight.
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“For patients who start on 2.4 mg and then hit a frustrating plateau, or for those with a very high baseline BMI who may need a stronger metabolic push, this creates a legitimate, evidence-based escalation path rather than forcing an early switch to another drug class,” Balazs, who was not involved in the study, told Fox News Digital.
“That said, I think this is an interesting approval, but I do not expect it to dramatically reshape the GLP-1 landscape,” he went on. “It gives Novo Nordisk an opportunity to remain competitive on efficacy while it continues developing next-generation therapies.”
“This creates a legitimate, evidence-based escalation path.”
“Other drugs have already shown greater efficacy in prior studies, and the broader GLP-1 space is likely to see much more significant change as new molecules enter the market.”
Balazs called the higher dosage a “major jump,” noting that the incidences of stomach- and skin-related side effects at this higher dose are “meaningful.”
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“This approval is for obesity management, not diabetes treatment,” the expert emphasized. “For patients with type 2 diabetes, currently approved semaglutide dosing remains lower unless the primary treatment goal is weight loss under the obesity indication.”
Fox News Digital reached out to the FDA for comment.
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