FDA gives rare approval to weight loss treatment

FDA gives rare approval to weight loss treatment
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The Food and Drug Administration (FDA) has given rare approval to a weight loss prescription device, its developer announced.

Biotechnology company Gelesis said that its product, Plenity, had been cleared for use by overweight or obese adults with a body mass index of at least 25, even if they do not have other health problems.


“This FDA clearance is a major milestone for the Gelesis team and our technology, and we are thrilled to be able to bring this new prescription product to the millions of people looking for a safe, validated and convenient treatment option to manage their weight without surgery or stimulants,” Yishai Zohar, founder and chief executive officer of Gelesis, said in a statement.

“With PLENITY, Gelesis is introducing a completely new approach with a unique mechanism of action to aid in weight management, with efficacy and safety supported by positive data from large clinical studies,” Zohar added.

The president and CEO of the Obesity Action Coalition praised Plenity's clearance in the Gelesis announcement, noting the need for more treatment options.

“Given the complexity of the disease of obesity and the need for expanded treatment options, the Obesity Action Coalition is encouraged to see continued innovation in safe and effective chronic weight management options," Joe Nadglowski said. "We welcome PLENITY’s addition as a treatment option for people affected by obesity.”

The FDA explained in a tweet that the product is "a gelatin capsule containing hydrogel particles that’s ingested & occupies space in the stomach to create a feeling of fullness" and recommended its use "in conjunction with diet and exercise."

The agency has frequently warned against the use of supplements, saying they can cause serious harm.

The FDA has only approved five prescription weight-loss drugs, according to Time magazine.

--This report was updated at 3:22 p.m.