FDA Approves Prescription Weight Management Therapy

The daily oral capsule was shown to reduce overweight and obese patient weight by about 6% over 6 months.

This weekend, US Food and Drug Administration approved a therapy designed to provide weight management aid to overweight adults.

Plenity, the oral, non-stimulant and non-systemic hydrogel therapy from Gelesis, was approved by the FDA in conjunction with diet and exercise to treat weight management in overweight and obese adults, as gauged by a body mass index (BMI) between 25-40 kg/m2. Its approval marks a major milestone, as Plenity is the first prescribed weight-management aid in the US for overweight adults with a BMI as low as 25 kg/m2. The current adult population it is designated to treat is nearing 75 million in the US, according to Gelesis.

The novel therapy is administered via oral capsules taken before lunch and dinner. A three-dimensional hydrogel matrix is created through the crosslinking of cellulose and citric acid—2 naturally-derived building blocks. The thousands of non-aggregating particles that are released to absorb water in the patients’ stomach create individual gel pieces that resemble the elasticity of plant-based foods.

The non-caloric gels increase the volume and elasticity of the patients’ stomach and small intestine contents, and create a sensation of fullness.

The clinical benefit of Plenity, as well as its prototypes, were assessed in 5 studies conducted in the US, Canada, and Europe. A recent multicenter, double-blind, placebo-controlled pivotal trial called Gelesis Loss of Weight (GLOW) tracked change in body weight among 436 adults with overweight or obesity (BMI ≥ 27 and ≤ 40 kg/m2) following 6 months of therapy.

Investigators reported that 59% of treated adults achieved a weight loss of 5% or greater. The mean weight loss for treated patients (6.4%) was superior to those administered placebo (4.4%; P= .0007). Treated patients also reported two-fold greater odds of achieving a weight loss of at least 5% versus placebo (OR 2.0; P= .0008).

Another quarter (26%) of treated adults reported a weight loss of 10% or greater. Adverse event (AE) incidence was similar in both treatment groups, with the most common treatment-related AEs being gastrointestinal disorders, infections and infestations, and musculoskeletal and connective tissue disorders.

Ken Fujioka, MD, a scientific advisor to Gelesis and endocrinology researcher for Scripps Clinic, noted the majority of individuals suffering from weight issue also report medical problems associated with their weight. He called making a significant impact on this issue “America’s number 1 public health priority.”

“The scientific data supporting Plenity’s positive effects on weight make it a powerful tool to help with weight management,” he said in a statement. “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.”

Gelesis intends to launch Plenity in a targeted approach during the second half of 2019, and to make it broadly available by prescription in the US in 2020.