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The Food and Drug Administration (FDA) has given its rare approval to a weight loss prescription, announced its developer.
The biotech company Gelesis stated that its product, Plenity, had been licensed to be used by overweight or obese adults with a body mass index of at least 25, even if they did not exhibit any symptoms. Other health problems.
"This authorization from the FDA is a major step for the Gelesis team and for our technology. We are excited to be able to offer this new prescription product to millions of people looking for a safe, validated and convenient treatment option to manage their weight without surgery. or stimulants, "said Yishai Zohar, founder and CEO of Gelesis, in a statement.
"With PLENITY, Gelesis introduces a completely new approach with a unique mechanism of action to help weight management, with efficacy and safety being confirmed by the positive clinical trial data of ############################################################################ Scale, "added Zohar.
The President and CEO of the Obesity Action Coalition has praised Plenity's clearance in the Gelesis announcement, stressing the need for more treatment options .
"Given the complexity of the disease of obesity and the need to expand treatment options, the Obesity Action Coalition is encouraged to continue to innovate in chronic weight management options. safe and effective, "said Joe Nadglowski. "We are looking forward to the addition of PLENITY as a treatment option for people with obesity".
The FDA has frequently warned against the use of weight loss drugs, claiming that they can cause serious damage.
The agency has approved only five prescription weight loss medications, according to Time magazine.
The Hill solicited comments from the FDA.
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