June 7, 2021 – The FDA has approved a drug that helps with weight loss in overweight or obese adults.
The drug, semaglutide, “reduces weight by reducing hunger, increasing the feeling of satiety, thereby helping people to eat less and reducing their calorie intake,” the company said in a statement.
Novo Nordisk plans to launch the drug in the United States later this month under the Wegovy brand.
The drug for weight loss is currently being reviewed by the European Medicines Agency.
Several experts say that this drug can seriously change the care of patients when it comes to weight loss.
The drug has been tested in clinical trials
The FDA’s positive decision is based on the results of four Phase III clinical trials that tested the safety and efficacy of the drug in more than 4,500 overweight or obese adults. Test participants received either a reduced-calorie diet, increased physical activity, or lifestyle interventions plus semaglutide.
The results were published in: New England Journal of Medicine:, The Lancet: , և: HOURS: February-March 2021.
In three of the four experiments on overweight people, members of the semaglutidine group saw 15-18% weight loss at 68 weeks.
The dose is well tolerated. The most common side effects were with the gastrointestinal tract, being “short, light” or moderate.
The co-author of the first experiment, Rachel Butterham, PhD, from the Center for Obesity Research at University College London, said in a statement: “The results of this study are a major step forward in improving the health of obese people.”
“No other drug has approached this level of weight loss. This is really a change of game. “For the first time, people can achieve what was possible with drugs only through weight loss surgery,” he added.
A welcome addition, but insurance will cover it.
Invited to comment on the FDA approval, Thomas A. which the medical staff and their obese patients were waiting for. ”
There are concerns about insurance coverage and pricing, said Waden, who potentially blocks the use of the drug.
“I hope millions of people in the United States and around the world who can benefit from this drug will eventually have access to it,” Waden said. “In the United States, the coverage of anti-obesity drugs by insurers and employers needs to be improved for that to happen. The drug has to be reasonably priced. “These changes are crucial to making this medicine the game change that can be.”
“This confirmation is a significant development,” said Scott Kahan, director of the National Weight Loss Center in Washington, D.C., in an e-mail to Medscape Medical News, who was not involved in the clinical trials of the drug.
“In an area with relatively few drug options, the availability of additional anti-obesity medications is welcome,” he said. “In particular, semaglutide has been shown to have impressive efficacy and safety data, as such it should be a valuable clinical option for many patients.”
While the drug could be a viable option for many patients, access to obesity treatment has traditionally been a challenge, Kahan warned.
“Novo Nordisk’s other obesity drug, Saxenda, has been a valuable tool, but one that very few patients can use because of the very low cost of insurance coverage,” he said. However, the “availability of obesity treatment” is a concern. “It has traditionally been a challenge,” Kahan warned. “Novo Nordisk’s other obesity drug, Saxenda, has been a valuable tool, but one that very few patients can use because of the very low cost of insurance coverage.”
“It remains to be seen how much semaglutide will be available to patients,” Kahan said. “Still, if the challenge of limited, high-cost coverage can be mitigated, this drug has the potential to significantly change the current paradigm of care, which has so far included minimal use of medication outside of specialist clinics,” he said.