FDA OKs Prescription Weight Management Therapy

Officials with the US Food and Drug Administration have approved a therapy designed to provide weight management aid to overweight adults.

Officials with the US Food and Drug Administration have approved a therapy, Plenity, by PureTech Health affiliate Gelesis, which is designed to provide weight management assistance to overweight adults.

To be used in conjunction with diet and exercise, Plenity is an orally-administered capsule containing a nonstimulant, nonsystemic, superabsorbent hydrogel that is designed to absorb water and increase the volume and elasticity of the stomach and small intestine contents to help people feel full. 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 or without comorbidities such as hypertension, type 2 diabetes or dyslipidaemia.

In clinical studies, Plenity demonstrated a unique combination of effectiveness combined with a favorable safety and tolerability profile. Data from the Gelesis Loss Of Weight (GLOW) study, were published recently in the scientific journal Obesity. Pivotal data from the GLOW study were also presented in 3 posters, one receiving a special recognition award, and an oral presentation at the Obesity Society Annual Meeting 2018.

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. 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 incidence was similar in both treatment groups.

Officials with Gelesis noted in a press release that they plan to initiate a targeted US launch in the second half of 2019.

Reference

1. Greenway FL, Aronne LJ Raben A, et al. Randomized, Double‐Blind, Placebo‐Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss. Obesity. 2018; 27(2)>