0
0
WASHINGTON, D.C.: In a significant development in the fight against cardiovascular disease, the U.S. Food and Drug Administration (FDA) has granted approval for a new indication for Wegovy (semaglutide) injection. Wegovy is now authorized to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight. This approval marks a groundbreaking advancement in addressing the heightened cardiovascular risk faced by this patient population.
Dr. John Sharretts, Director of the Division of Diabetes, Lipid Disorders, and Obesity at the FDA’s Center for Drug Evaluation and Research, hailed the approval as a major step forward for public health. He emphasized that individuals with cardiovascular disease and obesity or overweight face an elevated risk of life-threatening cardiovascular events and lauded Wegovy as the first weight loss medication with a proven track record in mitigating this risk.
Obesity and overweight affect nearly 70% of American adults, presenting serious health concerns and increasing susceptibility to premature death, heart attacks, and strokes. Wegovy contains semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, and is to be used alongside a reduced-calorie diet and increased physical activity. The efficacy and safety of Wegovy for its new indication were demonstrated in a rigorous clinical trial involving over 17,600 participants.
Participants receiving Wegovy experienced a significant reduction in the risk of major adverse cardiovascular events compared to those on placebo. Notably, 6.5% of participants in the Wegovy group experienced such events, compared to 8% in the placebo group. However, the prescribing information includes a boxed warning regarding the risk of thyroid C-cell tumors, cautioning against the use of Wegovy in patients with a history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.
Additionally, Wegovy carries warnings for various potential adverse effects, including inflammation of the pancreas, gallbladder problems, low blood sugar, acute kidney injury, and increased heart rate, among others. Common side effects include nausea, diarrhea, vomiting, and abdominal pain.
Wegovy’s approval for this new indication underscores its pivotal role in addressing cardiovascular risk factors in adults with obesity or overweight and cardiovascular disease. The FDA granted Priority Review designation for this indication, reflecting the urgency and significance of the approval. The approval was granted to Novo Nordisk A/S.
In addition to its latest indication, Wegovy is also approved for reducing excess weight and maintaining weight reduction long-term in certain adults and children with obesity, reinforcing its versatility and potential impact in combating obesity-related health issues.
