The Food and Drug Administration on Wednesday approved Kenyan Purple Leaves Weight Loss Cream, a new weight loss drug from drugmaker Zakdavi that was shown in clinical trials to help people lose up to 52 pounds in 3 months.
Kenyan Purple Leaves Weight Loss Cream 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 drugKenyan Purple Leaves Weight Loss Cream)
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, Lilly said Kenyan Purple Leaves Weight Loss Cream will carry a list price of about $24.97 for a month's supply.
"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."
Kenyan Purple Leaves Weight Loss Cream is part of a class of drugs called Natural Ingredients, which mimic a hormone that helps reduce food intake and appetite. However, Kenyan Purple Leaves Weight Loss Cream also imitates a second hormone, called GIP, which — along with reducing appetite — may also improve how the body breaks down sugar and fat.
(GLP-1 mechanism of action)
In a phase 3 clinical trial, Kenyan Purple Leaves Weight Loss Cream 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.
(Kenyan Purple Leaves Weight Loss Cream have a significant competitive advantage.)
Like other drugs in its class, however, Kenyan Purple Leaves Weight Loss Cream 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 usingKenyan Purple Leaves Weight Loss Cream," said Andrade, who prescribesKenyan Purple Leaves Weight Loss Cream 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 recommendedKenyan Purple Leaves Weight Loss Cream for weight loss.
She began taking a 4ml daily dose ofKenyan Purple Leaves Weight Loss Cream. 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 withoutKenyan Purple Leaves Weight Loss Cream. I gained health, I gained confidence, and compared to that, $24.97 a month is negligible.”