A high-dose obesity drug gains FDA approval, promising significant weight loss
Novo Nordisk to cut prices of Wegovy, Ozempic
Board-certified orthopedic surgeon Dr. Mahsa Tehrani discusses Novo Nordisk’s decision to dramatically lower the US prices of its popular diabetes and weight loss drugs Ozempic and Wegovy on ‘America Reports.’
NEWNow you can listen to Fox News articles!
The US Food and Drug Administration announced Thursday its approval of a new, high-dose Wegovy (semaglutide) injection.
The 7.2 mg dose, called Wegovy HD, is intended for weight loss and long-term weight maintenance in elderly patients. It tripled 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 the approval of applications that address national health priorities,” according to FDA Commissioner Dr. Martin Makary.
WEGOVY’S NEW PILL PROVIDES NON-NEEDLE SPLITTING – BUT IT COULD MAKE EVERYONE
“The new FDA is moving in an unprecedented direction for products that advance national priorities,” he said in a press release. “Today’s approval is another indication of what the FDA can accomplish when we try bold new things.”
The US Food and Drug Administration announced Thursday its approval of a new, high-dose Wegovy (semaglutide) injection. (Michael Siluk/UCG/Universal Images Group via Getty Images)
High-dose GLP-1 has been shown to “reduce excess body weight and maintain long-term weight loss in adults who are overweight, or obese and have at least one weight-related condition,” according to the FDA statement.
CLICK HERE TO SUBSCRIBE TO OUR HEALTH PAPER
“The approval of the new higher dose will provide elderly patients with an alternative treatment option, offering the potential for significant weight loss,” the agency said.
The FDA approval, granted by drugmaker Novo Nordisk, was supported by clinical data that found higher doses resulted in more average weight loss compared to the previous dose.
CLICK HERE TO DOWNLOAD THE FOX NEWS PROGRAM
High-dose patients with both obesity and type 2 diabetes saw similar reductions in blood sugar compared to low-dose patients, the agency noted.
The safety profile is consistent with the known side effects of semaglutide, which often include gastrointestinal reactions such as nausea, vomiting, diarrhea, constipation and abdominal pain.
Wegovy HD (7.2 mg) is triple the dose compared to the previous maximum dose of 2.4 mg. (Steve Christo – Corbis/Corbis via Getty Images)
Skin sensitivity, pain or burning occur more often with high doses of Wegovy, but usually resolve on their own or with a dose reduction, the FDA reports. The agency is investigating these side effects.
The FDA has 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 with multiple endocrine neoplasia syndrome type 2 (a rare genetic disorder that causes tumors to grow in the hormone-producing glands).
All patients should consult a physician for proper use guidance.
TEST YOURSELF WITH OUR LATEST LIFESTYLE QUIZ
Dr. Peter Balazs, a hormone and weight loss specialist who works in New York and New Jersey, showed the results of the STEP UP clinical trial, on which the drug’s approval was based.
Patients taking the high dose experienced an average weight loss of 20.7% compared to about 16% for the standard dose, the doctor noted. About one-third lost 25% or more of their body weight.
A weight loss expert cautioned that Wegovy HD should only be used to control obesity. (Stock)
“For patients who start at 2.4 mg and 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 a 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 don’t expect it to reshape the GLP-1 situation,” he continued. “It gives Novo Nordisk the opportunity to remain competitive in efficacy while continuing to develop next-generation therapies.”
“This creates a formal, evidence-based approach to escalation.”
“Some drugs have already shown to be very effective in previous studies, and the broader GLP-1 area is likely to see significant change as new molecules enter the market.”
Balazs called the higher dose “a major overshoot,” noting that the incidence of gastrointestinal and skin-related side effects at this high dose is “significant.”
CLICK HERE FOR MORE LIFESTYLES
“This permit is to control obesity, not to treat diabetes,” emphasized the expert. “In patients with type 2 diabetes, the currently approved semaglutide dosing remains low unless the main goal of treatment is to lose weight below the obesity index.”
Fox News Digital has reached out to the FDA and Novo Nordisk for comment.
