Another win for Wegovy: FDA approves higher semaglutide dose as part of new pilot program
Novo Nordisk has secured U.S. Food and Drug Administration (FDA) approval for a higher dose of its popular semaglutide injections. Adult patients will be eligible for the new dose if they have tolerated the standard 2.4-mg dosage for at least four weeks and still seek additional weight loss.
The company has been selling the current dosage of semaglutide under the brand name Wegovy; this new 7.2-mg dosage will be sold as Wegovy HD.
“We are excited to bring Wegovy HD injection to adults with obesity who are looking for powerful weight loss, as no other weight loss medicine has been studied to show superiority to Wegovy HD,” Jamey Millar, executive vice president of U.S. operations at Novo Nordisk, said in a statement. “In addition to significant weight loss, Wegovy is the only GLP-1 for adults with obesity that is proven to reduce the risk of events such as stroke, heart attack, or cardiovascular death in those who also have known heart disease. Today’s milestone expands the strong clinical profile of Wegovy that includes multiple indications that no other GLP-1 for weight loss can claim.”
Wegovy HD should be available to adult patients in April.
FDA approval was part of new pilot program
The FDA reviewed data from the STEP UP trial when considering this approval. The randomized, double-blinded, placebo-controlled analysis included nearly 1,500 adults without diabetes who presented with a BMI ≥30 kg/m2. Patients were randomized 5:1:1 to receive once-weekly injections of the higher dosage, the original dosage or a placebo. The 72-week trial confirmed that the higher dose was associated with clear cardiovascular benefits.
Early results from the STEP UP trial were published in The Lancet Diabetes & Endocrinology in November 2025.[1]
The FDA’s decision fell under the Commissioner’s National Priority Voucher (CNPV) pilot program, a new pathway for expediting the approval of certain therapies that “address critical national health priorities.” Companies chosen for this program receive a voucher that entitles them to certain benefits, including improved communication with federal regulators and a faster review process. This represents the fourth approval the FDA has granted under the CNPV program.
“The new FDA is moving with unprecedented efficiency on products that advance national priorities,” FDA Commissioner Martin Makary, MD, MPH, said in a separate statement. “Today’s approval is another demonstration of what the FDA can accomplish when we try bold new things.”
The continued rise of GLP-1 receptor agonists such as semaglutide has been one of modern medicine’s biggest stories. These drugs were originally developed to treat type 2 diabetes, but they have now been linked to multiple cardiovascular benefits and significant weight loss in patients with and without diabetes.
In October, the FDA even approved an oral version of semaglutide for reducing the risk of major adverse cardiovascular events in certain high-risk patients with type 2 diabetes.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.