Agency’s action could widen access to the drug if more insurance companies decide to cover it
By Physician’s Briefing Staff HealthDay Reporter
FRIDAY, March 8, 2024 (HealthDay News) — The U.S. Food and Drug Administration has approved Wegovy (semaglutide) for the prevention of myocardial infarction, stroke, and cardiovascular death in patients with obesity or overweight.
In one multinational study involving more than 17,600 people, participants received either injected Wegovy or a placebo injection. All participants also received standard-of-care management of their blood pressure and cholesterol plus counseling on exercise and healthy eating.
“Wegovy significantly reduced the risk of major adverse cardiovascular events (cardiovascular death, heart attack, and stroke), which occurred in 6.5 percent of participants who received Wegovy compared to 8 percent of participants who received placebo,” the FDA said.
It is thought that this expanded approval from the FDA could remove barriers from insurance companies when it comes to covering Wegovy. That could greatly expand the number of people who might be prescribed the drug.
Wegovy does have potential side effects, the agency said, including nausea, diarrhea, vomiting, abdominal pain, headache, fatigue, dizziness, hypoglycemia in patients with diabetes, flatulence, and gastroesophageal reflux disease. Patients taking Wegovy may also face increased risks for pancreatitis, gallbladder problems, hypoglycemia, acute kidney injury, hypersensitivity reactions, diabetic retinopathy, increased heart rate, and suicidal behavior or thinking. Using Wegovy along with insulin also raises risks for hypoglycemia.
“The prescribing information for Wegovy [also] contains a boxed warning to inform health care professionals and patients about the risk of thyroid C-cell tumors,” the FDA said, so it should not be used by people with a personal or family history of medullary thyroid carcinoma.
The expanded approval of Wegovy was granted to Novo Nordisk.
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