FDA approves Plenity from Gelesis

Gelesis, a biotechnology company focused on obesity and gastrointestinal tract disease treatments,  has received the Food and Drug Administration’s blessing for Plenity (Gelesis100). The drug is indicated as an aid in weight management in adults with a body mass index of 25 to 40 kg/m2, when used in conjunction with diet and exercise.

A BMI of 25 kg/m2 and over is the accepted definition of overweight, and a BMI of 30 kg/m2 and above commonly defines obesity.

“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,” Gelesis founder and CEO Yishai Zohar said. “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.”

Plenity is administered in the form of capsules taken with water before lunch and dinner. It is made by cross-linkingcellulose and citric acid to create a three-dimensional hydrogel matrix. The capsules release thousands of non-aggregating particles that rapidly absorb water in the stomach, creating small individual gel pieces with the elasticity of plant-based foods (e.g., vegetables) without caloric value. The gel pieces increase the volume and elasticity of the stomach and small intestine contents, contributing to a feeling of fullness and inducing weight loss.

“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. We welcome Plenity’s addition as a treatment option for people affected by obesity,” Obesity Action Coalition president and CEO Joe Nadglowski said.

Gelesis plans to launch Plenity in the second half of 2019 and anticipates the product will be broadly available by prescription in the United States in 2020.