FDA approves “game changer” drug for weight loss

June 7, 2021 — The FDA Weight loss Between Overweight Or Obese grown up.

medicine, SemaglutideAccording to a company statement, “It causes weight loss by reducing hunger and increasing satiety, thereby reducing the amount of food people eat and reducing calorie intake.”

Novo Nordisk plans to launch the drug in the United States later this month, given the brand name Wegovy.

Is Weight loss drug Currently under review by the European Medicines Agency.

Some experts say the drug can seriously change patient care when it comes to weight loss.

Drugs tested in clinical trials

The FDA’s favorable ruling is based on the results of four Phase III. Clinical trial Tested drug safety and efficacy in more than 4,500 adults Overweight Or obesity. Participants received either a low-calorie diet plan or a high-calorie diet plan. Physical activity Or lifestyle intervention and semaglutide.

Result is, New England Journal of Medicine, Lancet , And JAMA February and March 2021.

In three of the four trials of overweight and obese individuals, subjects in the semaglutide group lost 15% to 18% of weight in 68 weeks.

The dose was well tolerated. The most common side effects are the gastrointestinal tract, which were short-lived and mild or moderately severe.

Dr. Rachel Batterham of the University College London Obesity Research Center, co-author of the first trial, said at the time of publication of this paper:

“No other drug can achieve this level of weight loss. It’s just a game changer. For the first time, drugs can achieve what only weight loss surgery could do,” she added.

Additions are welcome, but can insurance cover them?

Dr. Thomas A. Waden of the University of Pennsylvania Perelman School of Medicine, invited to comment on FDA approval, was the lead author of the third trial, “Semaglutide appears to be a breakthrough in weight management and its healthcare providers. That’s what obese patients have been waiting for. “

Concerns over insurance coverage and pricing could prevent the drug from being used, Wadden said.

“We hope that millions of people in the United States and around the world who may benefit from this drug will eventually have access to it,” Wadden said. “In the United States, insurers and employers need to improve the coverage of anti-obesity drugs to ensure this is achieved, and the drugs must be reasonably priced. These changes are this. It’s important to make the drug a game changer. “

“This approval is an important step forward,” said Dr. Scott Kahan, MD, director of the National Center for Weight and Health in Washington, DC, who was not involved in the drug’s clinical trials, but also emailed Medscape Medical News. Said in.

“In areas where there are relatively few dosing options, the availability of additional obesity treatments is welcome,” he said. “In particular, semaglutide presents impressive data on efficacy and safety and should be a valuable clinical option for many patients.”

Access to obesity treatment has traditionally been a challenge, Kahan warned, although the drug could be a viable option for many patients.

“Saxender, Novo Nordisk’s other obesity treatment, is a valuable tool, but with minimal insurance reimbursement and very high costs, very few patients are available,” he said. It was. It was traditionally a challenge, “Kahan warned. “Saxender, Novo Nordisk’s other obesity treatment, is a valuable tool, but with minimal insurance reimbursement and very high costs, very few patients are available.”

“We still don’t know how easy it is for patients to use semaglutide,” Kahan said. “Still, if the limited scope and high cost challenges can be alleviated, the drug could significantly change the current treatment paradigm that has traditionally minimized the use of medications outside of specialized clinics. There is, “he continued.