After An FDA Label Modification – The use of Wegovy is no longer limited to weight loss alone. Novo Nordisk’s application to add cardiovascular benefits to the medicine’s label was approved by the Food and Drug Administration of the United States on Friday. This makes the medicine the first weight-loss drug to also be cleared to reduce the risk of heart attack, stroke, or death related to the heart in individuals who are at a higher risk of these conditions. Wegovy, which will cost more than $1,300 per month out of pocket before any discounts are applied, may see an improvement in insurance coverage as a result of the label expansion.
It is difficult for patients to afford weight reduction medications because many insurance companies, including Medicare, do not cover these medications. “The evidence is that they reduce risk and save lives, and as a result, it is indefensible to deny people access to medications that will directly improve their health, or to make it difficult for people to access medications that will do so,” Dr. Harlan Krumholz, a cardiologist and scientist at Yale University and Yale New Haven Hospital, stated on Friday.
He does not have any conflicts of interest and has not received any funds from Novo Nordisk or Eli Lilly, both of which produces drugs that are in direct competition with his own. “What is important to remember is that these drugs are not about beauty but rather about health. By treating obesity, we are aware that we can lower the risk of cardiovascular disease, and this may be just one of the many benefits that result from this treatment. An permission was granted on the basis of a study that involved 17,000 patients and demonstrated that individuals who took Wegovy, which is the sister medicine of the more well-known Ozempic, had a 20% decreased chance of experiencing a cardiac event compared to those who took a placebo.
Wegovy is recommended for individuals who have a body mass index (BMI) of at least 30 – which is regarded to be obese – or those who have a BMI of at least 27 – which is considered to be overweight – and at least one “weight-related” health issue such as high blood pressure or cholesterol. The use of Ozempic treating type 2 diabetes has been approved. Both of these medications include the active component semaglutide, which belongs to a category of medications known as GLP-1 receptor agonists.
“Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight,” Dr. John Sharretts, the director of the Division of Diabetes, Lipid Disorders, and Obesity at the Food and Drug Administration, said in a press release issued by the agency.
He continued by saying, “This patient population has a higher risk of fatal cardiovascular events, including heart attacks and strokes.” It is a significant step forward for public health to be able to offer a treatment option that has been demonstrated to reduce the risk of cardiovascular disease.
People with cardiovascular disease participated in the trial conducted by Novo Nordisk. This means that they had experienced a heart attack or stroke in the past, or they exhibited indications of peripheral artery disease, which is characterized by clogged arteries in the arms or legs. To determine whether or if there are benefits to the heart for individuals who have not experienced a cardiac episode, additional research needs to be conducted.
There is still a shortage of Wegovy and other GLP-1 treatments, as pharmaceutical companies are having trouble keeping up with the demand for these medications. It was announced by Novo Nordisk one month ago that the company will be steadily expanding the supply throughout the course of this year. “The shortages are really, really bad right now,” Dr. Jody Dushay, an endocrinologist at Beth Israel Deaconess Medical Center and an assistant professor of medicine at Harvard Medical School, said on Friday. “The shortages are really, really bad.” She stated that she does not have any connections to the pharmaceutical industry.
It was her goal that the enlarged approval would result in an improvement in insurance coverage, particularly in light of the fact that generic alternatives to weight-loss drugs can be associated with heart risks. However, she also mentioned that “if insurance comes on board with this indication,” she has “no idea how manufacturing will ever catch up.”
With that being said, Dushay went on to say that “this might also help prioritize use of [the drugs] among those with highest-risk obesity,” which includes individuals who already have cardiovascular disease. Doug Langa, who is the head of North America Operations for Novo Nordisk, stated in a press release that was issued on Friday that the business is striving “to increase manufacturing capacity to responsibly supply this important medicine.”
