Higher doses of obesity drugs are approved by the US Food and Drug Administration and promise greater weight loss
The U.S. Food and Drug Administration on Thursday announced its approval of a new higher-dose Wegovy (semaglutide) injection.
The 7.2 mg dose, called Wegovy HD, is intended for use Weight loss and maintenance of long-term weight loss for adult patients. This is three times the previous maximum dose of 2.4 mg.
This marks the fourth approval in the FDA’s National Priority Voucher Program, which “seeks to accelerate approval of applications that address critical national health priorities,” according to FDA Commissioner Dr. Martin McCurry.
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“The new FDA moves with unprecedented efficiency on products that advance national priorities,” he said in a press release. “Today’s approval is further evidence of what the FDA can accomplish when we try bold, new things.”
The U.S. Food and Drug Administration on Thursday announced its approval of a new higher-dose Wegovy (semaglutide) injection. (Michael Sellock/UCG/Universal Images Group via Getty Images)
The higher dose of GLP-1 is indicated to “reduce excess body weight and maintain weight loss over the long term.” Adults with obesityor overweight with at least one weight-related condition,” according to the FDA statement.
“Approval of a new higher dose will provide adult patients with an additional treatment option, offering the potential for greater weight loss,” the agency stated.
The FDA approval, granted to pharmaceutical company Novo Nordisk, was supported by clinical data that found that higher doses resulted in additional weight loss compared to previous doses.
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Patients taking higher doses suffer from obesity and Type 2 diabetes The agency noted a similar reduction in blood sugar compared to the lower dose.
The safety profile is consistent with known side effects of semaglutide, which typically include: Gastrointestinal reactions Such as nausea, vomiting, diarrhea, constipation, and abdominal pain.
Wegovy HD (7.2 mg) is three times the dose compared to the previous maximum dose of 2.4 mg. (Steve Christo – Corbis/Corbis via Getty Images)
The FDA reported that skin sensitivity, pain, or burning occurred more frequently at higher doses of Wegovy, but generally resolved on its own or with dose reduction. The agency is investigating these harmful effects.
The US Food and Drug Administration (FDA) has warned that Wegovy should not be used by patients with a personal or family history of medullary thyroid cancer (a type of cancer). Thyroid cancer) or who have multiple endocrine neoplasia syndrome type 2 (a rare genetic disorder that causes tumors in some hormone-producing glands). All patients should see a physician for guidance on proper use.
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Jamie Millar, executive vice president of Novo Nordisk’s U.S. operations, commented on the approval in a press release.
“We are excited to offer Wegovy HD injections to adults with obesity who are looking for powerful weight loss, as no other weight loss medication 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 death from cardiovascular disease in those who also have heart disease.
A weight loss expert has warned that Wegovy HD should only be used to treat obesity. (Istock)
Dr. Peter Balazs, a hormone and weight loss specialist who practices in New York and New Jersey, spoke about the results of the STEP UP clinical trial, on which the drug’s approval was based.
The doctor noted that patients who took the highest dose experienced an average weight loss of 20.7%, compared to about 16% when taking the standard dose. About a third lost 25% or more of their body weight.
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“For patients who started at 2.4 mg and then reached a frustrating level, or for those with a very high baseline BMI who may need a stronger metabolic boost, this creates a legitimate, evidence-based escalation pathway rather than forcing an early switch to another drug class,” Balazs, who was not involved in the study, told Fox News Digital.
“However, I think this is an interesting approval, but I don’t expect it to significantly reshape the GLP-1 landscape,” he continued. “It gives Novo Nordisk the opportunity to remain competitive in terms of effectiveness as it continues its development Next generation treatments“.
“This creates a legitimate, evidence-based escalation path.”
“Other drugs have already shown greater efficacy in previous studies, and the broader GLP-1 field is likely to see more significant change as new molecules enter the market.”
Balazs described the higher dose as a “big jump,” noting that cases of stomach ulcers and Related to the skin Side effects at this higher dose are “meaningful.”
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“This approval is for obesity management, not… Treatment of diabetes“For patients with type 2 diabetes, the currently approved semaglutide doses remain lower unless the primary treatment goal is weight loss under the obesity index,” the expert emphasized.
Fox News Digital has reached out to the FDA for comment.
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