BOSTON: Gelesis, a biotechnology company developing first-in-class hydrogel therapeutics to treat obesity and other chronic diseases related to the gastrointestinal (GI) tract, today announced that the United States Food and Drug Administration (USFDA) has cleared the Company’s lead product candidate, PLENITY (Gelesis100), as an aid in weight management in adults with a Body Mass Index (BMI) of 25–40 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.
PLENITY represents a new prescription option for millions of adults. More than half of the approximately 150 million adults in the U.S. with a BMI ranging from 25 kg/m2 to 40 kg/m2 are classified as overweight (BMI 25-30 kg/m2).
Until now, many of them have not had any prescription treatment options. The safety and efficacy profile of PLENITY makes it well-suited for these individuals. It is the only prescription weight management product to be cleared for use by overweight adults with a BMI as low as 25 kg/m2, with and also without comorbidities such as hypertension, type 2 diabetes or dyslipidemia. There is no restriction on how long PLENITY can be used to assist in weight management.
Commenting on the grant, Yishai Zohar, founder and chief executive officer of Gelesis said, “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,” 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,” Zohar added.
PLENITY is administered in the form of capsules taken with water before lunch and dinner.
In clinical studies, PLENITY demonstrated a unique combination of effectiveness combined with a highly favorable safety and tolerability profile.
“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,” said Joe Nadglowski, president and chief executive officer of the Obesity Action Coalition.
“More than 150 million Americans struggle with excess or unhealthy weight. Unfortunately, the majority of individuals with weight issues have important weight-related medical problems. There is no doubt that making a significant impact on this issue should be America’s number one public health priority. The scientific data supporting PLENITY’s positive effects on weight make it a powerful tool to help with weight management. The most compelling aspects of this approach are its effectiveness, novel mechanism of action and impressive safety data. This approach creates another arm in the treatment algorithm of weight management and could be used by an overwhelming majority of people struggling with weight issues,” said Ken Fujioka, M.D., a weight loss expert, endocrinology researcher at Scripps Clinic and scientific advisor to Gelesis.
Gelesis plans to initiate a targeted U.S. launch of PLENITY in the second half of 2019 and anticipates PLENITY will be broadly available by prescription in the U.S. in 2020.