Greater weight loss promised by higher-dose Wegovy shot, now approved by FDA

The U.S. Food and Drug Administration announced connected Thursday its support of a new, higher-dose Wegovy (semaglutide) injection.

The 7.2 mg dosage, called Wegovy HD, is intended for weight loss and semipermanent weight nonaccomplishment attraction for big patients. It is triple nan erstwhile maximum dose of 2.4 mg.

This marks nan 4th support successful nan FDA's National Priority Voucher aviator program, which "seeks to expedite support of applications that reside captious nationalist wellness priorities," according to FDA Commissioner Dr. Martin Makary.

NEW WEGOVY PILL OFFERS NEEDLE-FREE WEIGHT LOSS – BUT MAY NOT WORK FOR EVERYONE

"The caller FDA is moving pinch unprecedented ratio connected products that beforehand nationalist priorities," he said successful a property release. "Today’s support is different objection of what nan FDA tin execute erstwhile we effort bold caller things."

The U.S. Food and Drug Administration announced connected Thursday its support of a new, higher-dose Wegovy (semaglutide) injection. (Michael Siluk/UCG/Universal Images Group via Getty Images)

The higher-dose GLP-1 is indicated to "reduce excess assemblage weight and support weight simplification semipermanent successful adults pinch obesity, aliases overweight pinch astatine slightest 1 weight-related condition," per nan FDA's statement.

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"The support of a caller higher dose will supply big patients pinch an further therapeutic option, offering nan imaginable for greater weight loss," nan agency stated.

The FDA’s approval, granted to drugmaker Novo Nordisk, was supported by objective information that recovered higher doses resulted successful further mean weight simplification compared to erstwhile dosing. 

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Higher-dose patients pinch some obesity and type 2 diabetes saw akin lowering of humor sweetener compared to nan little dose, nan agency noted.

The information floor plan is accordant pinch nan known broadside effects of semaglutide, which commonly see gastrointestinal reactions for illustration nausea, vomiting, diarrhea, constipation and abdominal pain.

Wegovy HD (7.2 mg) is triple nan dosage compared to nan erstwhile maximum dose of 2.4 mg. (Steve Christo - Corbis/Corbis via Getty Images)

Skin sensitivity, symptom aliases burning occurred much often pinch higher doses of Wegovy, but mostly resolved connected their ain aliases pinch dose reduction, nan FDA reported. The agency is investigating these adverse effects.

The FDA warned that Wegovy should not beryllium utilized by patients pinch a individual aliases family history of medullary thyroid carcinoma (a type of thyroid cancer) aliases who person aggregate endocrine neoplasia syndrome type 2 (a uncommon inherited familial upset that causes tumors to create successful definite hormone-producing glands). 

All patients should spot a expert for guidance connected due use.

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Dr. Peter Balazs, a hormone and weight-loss master practicing successful New York and New Jersey, reflected connected results of nan STEP UP objective trial, connected which nan drug's support was based.

Patients taking nan higher dose knowledgeable an mean weight nonaccomplishment of 20.7% compared to astir 16% connected nan modular dose, nan expert noted. About one-third mislaid 25% aliases much of their assemblage weight.

A weight-loss master warned that Wegovy HD should beryllium utilized only for obesity management. (iStock)

"For patients who commencement connected 2.4 mg and past deed a frustrating plateau, aliases for those pinch a very precocious baseline BMI who whitethorn request a stronger metabolic push, this creates a legitimate, evidence-based escalation way alternatively than forcing an early move to different supplier class," Balazs, who was not progressive successful nan study, told Fox News Digital.

"That said, I deliberation this is an absorbing approval, but I do not expect it to dramatically reshape nan GLP-1 landscape," he went on. "It gives Novo Nordisk an opportunity to stay competitory connected efficacy while it continues processing next-generation therapies."

"This creates a legitimate, evidence-based escalation path."

"Other narcotics person already shown greater efficacy successful anterior studies, and nan broader GLP-1 abstraction is apt to spot overmuch much important alteration arsenic caller molecules participate nan market."

Balazs called nan higher dosage a "major jump," noting that nan incidences of stomach- and skin-related broadside effects astatine this higher dose are "meaningful."

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"This support is for obesity management, not diabetes treatment," nan master emphasized. "For patients pinch type 2 diabetes, presently approved semaglutide dosing remains little unless nan superior curen extremity is weight nonaccomplishment nether nan obesity indication."

Fox News Digital reached retired to nan FDA and Novo Nordisk for comment.