A new, more powerful weight loss drug receives the green light from the FDA: “Big leap”

The US Food and Drug Administration on Thursday announced the approval of a new injection of Wegovy (semaglutide) in higher doses.

The 7.2 mg dose, called Wegovy HD, is intended for weight loss and long-term weight loss maintenance in adult patients. This 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 accelerate the 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 forward with unprecedented efficiency on products that advance national priorities,” he said in a news release. “Today’s approval is another demonstration of what the FDA can achieve when we try bold new things.”

The highest dose of GLP-1 is indicated to “reduce excess body weight and maintain long-term weight loss in adults who are obese or overweight with at least one weight-related condition,” according to the FDA statement.

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“The approval of a new higher dose will provide adult patients with an additional therapeutic option, offering the possibility of greater weight loss,” the agency stated.

The FDA approval, granted to drugmaker Novo Nordisk, was supported by clinical data that found higher doses resulted in additional average weight reduction compared to previous doses.

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Patients who received higher doses, both with obesity and type 2 diabetes, experienced a similar reduction in 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 such as 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 a 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 consult a physician for guidance on proper use.

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Jamey Millar, executive vice president of US operations at Novo Nordisk, commented on this approval in a press release.

“We are excited to bring Wegovy HD injection to obese adults seeking powerful weight loss, as no other weight loss medication has been studied to demonstrate superiority over 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 the 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% with the standard dose, the doctor noted. About a third lost 25% or more of their body weight.

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“For patients who start at 2.4 mg and then hit a frustrating plateau, or for those with a very high baseline BMI who may need a stronger metabolic boost, this creates a legitimate, evidence-based escalation path rather than forcing an early switch to another class of medication,” Balazs, who was not involved in the study, told News Digital.

“That said, I think this is an interesting approval, but I don’t expect it to dramatically change the outlook for GLP-1,” he continued. “It offers Novo Nordisk the opportunity to remain competitive in efficacy while continuing to develop next-generation therapies.”

“This creates a legitimate, evidence-based escalation path.”

“Other drugs have already demonstrated greater efficacy in previous studies, and the broader GLP-1 footprint is likely to undergo much more significant changes as new molecules enter the market.”

Balazs called the higher dose a “major jump,” noting that the incidence of stomach- and skin-related side effects with this higher dose is “significant.”

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“This approval is for the control of obesity, not for the treatment of diabetes,” the expert emphasized. “For patients with type 2 diabetes, the currently approved semaglutide dose remains lower unless the primary goal of treatment is weight loss under the indication of obesity.”

News Digital has contacted the FDA for comment.