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 value nonaccomplishment and semipermanent value nonaccomplishment attraction for big patients. It is triple the erstwhile maximum dose of 2.4 mg.

This marks the 4th support successful the FDA's National Priority Voucher aviator program, which "seeks to expedite support of applications that code 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 with unprecedented ratio connected products that beforehand nationalist priorities," helium said successful a property release. "Today’s support is different objection of what the 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 value and support value simplification semipermanent successful adults with obesity, oregon overweight with astatine slightest 1 weight-related condition," per the FDA's statement.

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"The support of a caller higher dose volition supply big patients with an further therapeutic option, offering the imaginable for greater value loss," the bureau stated.

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

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Higher-dose patients with some obesity and benignant 2 diabetes saw akin lowering of humor sweetener compared to the little dose, the bureau noted.

The information illustration is accordant with the known broadside effects of semaglutide, which commonly see gastrointestinal reactions similar nausea, vomiting, diarrhea, constipation and abdominal pain.

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

Skin sensitivity, symptom oregon burning occurred much often with higher doses of Wegovy, but mostly resolved connected their ain oregon with dose reduction, the FDA reported. The bureau is investigating these adverse effects.

The FDA warned that Wegovy should not beryllium utilized by patients with a idiosyncratic oregon household past of medullary thyroid carcinoma (a benignant of thyroid cancer) oregon who person aggregate endocrine neoplasia syndrome benignant 2 (a uncommon inherited familial upset that causes tumors to make successful definite hormone-producing glands). 

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

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

Patients taking the higher dose experienced an mean value nonaccomplishment of 20.7% compared to astir 16% connected the modular dose, the doc noted. About one-third mislaid 25% oregon much of their assemblage weight.

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

"For patients who commencement connected 2.4 mg and past deed a frustrating plateau, oregon for those with a precise precocious baseline BMI who whitethorn request a stronger metabolic push, this creates a legitimate, evidence-based escalation way alternatively than forcing an aboriginal power to different cause class," Balazs, who was not progressive successful the study, told Fox News Digital.

"That said, I deliberation this is an absorbing approval, but I bash not expect it to dramatically reshape the GLP-1 landscape," helium went on. "It gives Novo Nordisk an accidental to stay competitory connected efficacy portion it continues processing next-generation therapies."

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

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

Balazs called the higher dosage a "major jump," noting that the 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," the adept emphasized. "For patients with benignant 2 diabetes, presently approved semaglutide dosing remains little unless the superior attraction extremity is value nonaccomplishment nether the obesity indication."

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