Today, the U.S. Food and Drug Administration approved a new indication for the use of Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack, and stroke in obese or overweight adults with cardiovascular disease. . Wegovy should be used in addition to a reduced calorie diet and increased physical activity. Cardiovascular disease is a group of diseases of the heart and blood vessels.

“Wegovy is the first weight loss drug approved for use in the prevention of life-threatening cardiovascular events in obese or overweight adults with cardiovascular disease,” said John, Director of Diabetes and Dyslipidemia.・Dr. Sharetz said. Obesity at the FDA's Center for Drug Evaluation and Research. “This patient population is at increased risk for cardiovascular death, heart attack, and stroke. Providing treatment options proven to reduce this cardiovascular risk is a major advance for public health.”

Obesity or overweight affects approximately 70% of American adults. Obesity and overweight are serious health problems that increase the risk of premature death and various health problems such as heart attack and stroke.

Wegovy contains semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. Therefore, Wegovy should not be used in combination with other semaglutide-containing products or other GLP-1 receptor agonists.

The efficacy and safety of Wegovy for this new indication was studied in a multinational, multicenter, double-blind, placebo-controlled trial in which more than 17,600 participants were randomly assigned to receive either Wegovy or a placebo. Ta. Participants in both groups also received standard care (such as blood pressure and cholesterol management) and healthy lifestyle counseling (such as diet and physical activity). Wegovy significantly reduced the risk of major adverse cardiovascular events (cardiovascular death, heart attack, and stroke). This event occurred in 6.5% of participants who received Wegovy compared to 8% of participants who received a placebo.

Wegovy's prescribing information includes a boxed warning to inform health care professionals and patients about the risk of thyroid C-cell tumors. Because of this risk, Wegovy should not be used in patients with a personal or family history of medullary thyroid cancer or a rare disease called multiple endocrine tumor syndrome type 2.

Wegovy should not be used in patients with a history of severe allergic reactions to semaglutide or other ingredients. If a severe allergic reaction is suspected, the patient should immediately discontinue her Wegovy and seek medical attention.

Wegovy may be associated with inflammation of the pancreas (pancreatitis), gallbladder problems (including gallstones), hypoglycemia, acute kidney injury, hypersensitivity reactions, diabetic retinopathy (damage to the retina of the eye), increased heart rate, suicidal behavior, and Also includes a warning about suicidal thoughts. Patients should consult their health care provider if they have symptoms of pancreatitis or gallstones. If Wegovy is used with insulin or drugs that cause insulin secretion, patients should talk to their healthcare provider about the risk of hypoglycemia. Health care professionals should monitor patients for kidney disease, diabetic retinopathy, depression, and suicidal behavior or thoughts.

The most common side effects of Wegovy include: nausea, diarrhea, vomiting, constipation, abdominal (stomach) pain, headache, fatigue, indigestion (indigestion), dizziness, bloating, belching (belching), Includes blood sugar (hypoglycemia). Diabetes, bloating (gas buildup), gastroesophageal reflux disease (heartburn).

Wigovy received priority review Specify this display.

The FDA granted approval to Novo Nordisk A/S.

Wegovy is also approved for the reduction of excess weight and long-term maintenance of weight loss in certain adults who are obese or overweight and in certain children who are obese, in addition to a reduced-calorie diet and increased physical activity. I am.

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