LENITY 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
~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
PLENITY is a new orally administered, non-stimulant, non-systemic aid in weight management based on proprietary hydrogel technology with a highly favorable safety and efficacy profile demonstrated in clinical studies
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 (FDA) 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.
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