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Gelesis Receives FDA Clearance for First Product
Gelesis Receives FDA Clearance for First Product.
About this update from Puretech Health Plc
[{"type":"text","content":"\n \nRNS Number : 1235W PureTech Health PLC 15 April 2019 \n\n15 April 2019\n \nPureTech Health plc\n \nPureTech Health Affiliate Gelesis Announces Successful FDA Milestone for First Product, PLENITY™\n \nFDA Clearance of PLENITYTM is a landmark milestone for PureTech Health, which helped conceive and develop the platform \n \nPLENITY is FDA cleared for the largest number of adults struggling with overweight and obesity (BMI 25-40 kg/m2) of any prescription weight-management aid and the first that can be used, along with diet and exercise, in millions of overweight adults who have never before had prescription options\n \n~6 out of 10 adults treated with PLENITY were responders, losing on average 10% of their weight (22 pounds) and 3.5 inches from their waists within 6 months in pivotal study \n \nPLENITY is a new orally administered, non-stimulant, non-systemic aid in weight management based on proprietary hydrogel technology with a highly favourable safety and efficacy profile demonstrated in clinical studies \n \nWebcast and conference call today at 12:00PM BST / 7:00AM EDT\n \nPureTech Health plc (LSE: PRTC) (\"PureTech Health\"), an advanced biopharmaceutical company developing novel medicines for dysfunctions of the Brain-Immune-Gut (BIG) axis, today announced that its affiliate, Gelesis, has received marketing clearance from the United States Food and Drug Administration (FDA) for its first product, PLENITYTM(Gelesis100), a new and differentiated 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. Nearly 150 million adults in the United States fall into this wide BMI range. PLENITY 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. \n \nPLENITY is an orally administered capsule containing a non-stimulant, non-systemic, superabsorbent hydrogel. It is designed to absorb water and increase the volume and elasticity of the stomach and small intestine contents to help people feel full. 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 ...