The new FDA-approved ‘Wegovy HD’ offers three times the dose of semaglutide

The U.S. Food and Drug Administration announced Thursday that it is approving a new, high-dose Vigovi (semglutide) injection.

The 7.2 mg dose, called Vigovi HD, is intended for weight loss and long-term weight loss maintenance in 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 Pilot Program, which “accelerates approval of applications that address important national health priorities,” according to FDA Commissioner Dr. Martin Macri.

“The new FDA is moving with unprecedented efficiency on products that drive national priorities,” he said in a press release. “Today’s approval is another demonstration of what FDA can do when we try bold new things.”

High-dose GLP-1 is “indicated for the reduction of excess body weight and long-term maintenance of weight loss in adults with obesity or overweight,” according to the FDA statement.

“The approval of the new higher dose will provide an additional treatment option to adult patients, who are prone to weight gain,” the agency said.

The FDA approval, granted to drug maker Novo Nordisk, was supported by clinical data that found higher doses resulted in additional average weight loss compared to earlier doses.

The agency noted that both obese and type 2 diabetic patients on the high dose saw similar reductions in blood sugar compared to the low dose.

The safety profile is consistent with the known side effects of semaglutide, which typically include gastrointestinal reactions such as nausea, vomiting, diarrhea, constipation, and abdominal pain.

Skin sensitivity, pain or burning occurs more frequently with higher doses of Vigovi, but usually resolves on its own or with dose reduction, the FDA reported.

The agency is investigating these adverse effects.

The FDA warned that Vigovi should not be used by patients with a personal or family history of thyroid carcinoma (a type of thyroid cancer) or multiple endocrine neoplasia syndrome type 2 (a rare inherited genetic disorder that causes tumors to form in specific hormone-producing glands).

All patients should consult a physician for guidance on proper use.

Jamie Miller, executive director of US operations for Novo Nordisk, commented on the approval in a press release.

“We are excited to bring Vigovi HD injection to obese adults who are looking for powerful weight loss, as no other weight loss drug has been studied to demonstrate Vigovi HD’s superiority,” he said.

Miller also noted that Vigovi reduces the risk of events such as stroke, heart attack or cardiac death in those with known heart disease.

Dr. Peter Balazs, a hormone and weight loss specialist who practices in New York and New Jersey, reflected on the results of the STEP UP clinical trial, which was the basis for the drug’s approval.

The doctor noted that patients taking the high dose experienced an average weight loss of 20.7% compared to about 16% for the standard dose.

About one-third lost 25% or more of their body weight.

“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 stronger metabolic suppression, this creates a legitimate, evidence-based escape route rather than forcing an early switch to another drug class,” said Balazs, who was not involved in the NewsDigital study.

“That said, I think it’s an interesting approval, but I don’t expect it to dramatically change the GLP-1 landscape,” he said. “This gives Novo Nordisk the opportunity to remain competitive on efficiency while it continues to develop next-generation therapies.”

“Other drugs have already shown great efficacy in previous studies, and the broader GLP-1 space is likely to see more significant change as new molecules enter the market.”

Balazs called the higher dose “a big jump,” noting that the incidence of gastrointestinal and skin-related side effects at this high dose is “significant.”

“This approval is for the management of obesity, not for the treatment of diabetes,” emphasized Maher. “For patients with type 2 diabetes, the currently approved semaglutide dose remains low unless the primary goal of treatment is weight loss under the umbrella of obesity.”

Fox News Digital has reached out to the FDA for comment.