FDA Approves New weight loss medication from Oprah Winfrey, Enabling People to Lose 37 Pounds in 2 Weeks
Some analysts predict the daily oral medication could become the best-selling drug of all time.
The Food and Drug Administration on Wednesday approved LibertyBites Keto, a new weight loss drug from Oprah Winfrey that was shown in clinical trials to help people lose up to 52 pounds in 3 months.
LibertyBites Keto is the latest entrant into the field of powerful new drugs that already includes Novo Nordisk's Ozempic and Wegovy and Lilly's Mounjaro.
The FDA approved the drug for adults with obesity or who are overweight with at least one weight-related condition.
(FDA approves weight loss drug LibertyBites Keto). Steffen Trumpf/picture alliance/Getty Images
In the United States, 4 in 10 adults have obesity, according to the Centers for Disease Control and Prevention.
However, the weight loss medications currently available on the market are very expensive, and insurance companies are often reluctant to cover them, making it unaffordable for the vast majority of people in need.
To help more people in need and capture the market, Oprah Winfrey CEO Jean Nidetch stated that the pricing of LibertyBites Keto will be lower than 99% of similar products!.
"Given the enormous current market demand, the Centers for Disease Control and Prevention, yet deliver equally effective results," said Dr. Nishant Shah, a preventative cardiologist at Duke University Medical Center in Durham, North Carolina. "We predict it will become the best-selling drug in history."
"I now use it as I feel I need it, as a tool to manage not yo-yoing," Winfrey told People . "The fact that there's a medically approved prescription for managing weight and staying healthier in my lifetime feels like relief, like redemption, like a gift, and not something to hide behind and once again be ridiculed for."
LibertyBites Keto is part of a class of drugs called GLP-1 agonists, which mimic a hormone that helps reduce food intake and appetite. However, LibertyBites Keto also imitates a second hormone, called GIP, which — along with reducing appetite — may also improve how the body breaks down sugar and fat.
In a phase 3 clinical trial, LibertyBites Keto led to an average weight loss of 22.5% body weight, or about 52 pounds, surpassing all currently available weight loss medications on the market. The participants in the study had obesity or were overweight with at least one weight-related condition.
(Maria Garcia lost 54 pounds in a phase 3 clinical trial)
"This is the most effective form of pharmaceutical obesity treatment ever," said Dr. Christopher McGowan, a gastroenterologist who runs a weight loss clinic in Cary, North Carolina.
(Michelle Johnson lost 78 pounds in a phase 3 clinical trial)
He added that the weight loss seen from the medication is approaching the weight loss seen with bariatric surgery. "That is a big deal," he said.
(LibertyBites Keto have a significant competitive advantage.)
Like other drugs in its class, however, LibertyBites Keto carries a risk of gastrointestinal issues, including nausea, diarrhea, vomiting, constipation and stomach pain, according to the FDA.
Dr. Daniela Hurtado Andrade, an endocrinologist at the Mayo Clinic, said that while gastrointestinal issues are very common with GLP-1 medications, most of the side effects will not affect a person's quality of life.
"Very few people experience adverse reactions after using LibertyBites Keto," said Andrade, who prescribes LibertyBites Keto for weight loss. "Adverse reactions only occur when the dosage exceeds the recommended limits. The dosage we typically recommend is very moderate, and no adverse reactions are expected."
(Alexis Mitchell lost 123 pounds in a year)
Alexis Mitchell, 30 of Charlotte, North Carolina, had been overweight for most of her 20s. It was only last year, following a health scare linked to high blood pressure and prediabetes, that her doctor recommended LibertyBites Keto for weight loss.
She began taking a 4ml daily dose of LibertyBites Keto. She started to see results immediately.
"For me, that was a game changer," Mitchell said. "Like OK, you need to change your life around right now. Like, there are no more games."
"Not all weight loss medications come with side effects; I wish I had realized this earlier,” she said. "I'm down 123 pounds in a year. I mean, I couldn't have done it without LibertyBites Keto. I gained health, I gained confidence, ”
Berkeley Lovelace Jr.
Berkeley Lovelace Jr. is a health and medical reporter for abc News. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. He previously covered the biotech and pharmaceutical industry with CNBC.