Gelesis Granted FDA Clearance to Market PLENITY™ — a New Prescription Aid in Weight Management


2019-04-15 17:15:53 BioSpace


标签: 医疗学科 自身免疫病
PLENITY is FDA cleared for the largest number of adults struggling with overweight and obesity 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 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 (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. Gelesis Granted FDA Clearance to Market PLENITY™ - a New Prescription Approach to Weight Management 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. “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 Yishai Zohar, founder and chief executive officer of Gelesis. “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.” PLENITY is administered in the form of capsules taken with water before lunch and dinner. PLENITY is made by cross-linking two naturally-derived building blocks – cellulose and citric acid – to create a three-dimensional hydrogel matrix. The capsules release thousands of non-aggregating particles that rapidly absorb water in the stomach, creating small individual gel pieces with the elasticity (firmness) of plant-based foods (e.g., vegetables) without caloric value. The gel pieces increase the volume and elasticity of the stomach and small intestine contents, contributing to a feeling of fullness and inducing weight loss. This novel, non-stimulant and non-systemic treatment has been shown in clinical studies to be effective, safe and well-tolerated.
处方体重管理方式PLENITY获FDA许可用于多数患有超重与肥胖的成人用户,该方式是首个与食疗和锻炼联合使用的处方管理方案,适用于上百万未尝试过处方方案的超重成人。 在接受PLENITY治疗的10名成年人中,有6人反应正常,在关键的研究中,他们的平均体重(22磅)减少了10%,腰围平均减少了3.5英寸 PLENITY是一种新型的口服、非刺激性、非全身性的基于专有水凝胶技术的体重管理辅助工具,临床研究显示其安全性和有效性非常好 波士顿 -- Gelesis ,一家生物技术公司,开发了一流的水凝胶疗法来治疗肥胖和其他与胃肠道相关的慢性疾病,今天宣布FDA已经许可了该公司的主要产品候选者PLENITY ™(Gelesis100)。该疗法与饮食和运动结合使用,作为体重指数( BMI )为25-40 kg / m2的成年人体重管理的辅助手段。体重指数为25公斤/平方米及以上是公认的超重定义,体重指数为30公斤/平方米及以上通常定义肥胖。 Gelesis公司全新处方减肥管理方式PLENITY获FDA上市许可 对数以百万计的成年人来说,PLENITY是一种新的处方选择。在美国约1.5亿成年人中,体重指数在25公斤/平方米到40公斤/平方米之间的一半以上被列为超重(体重指数为25-30公斤/平方米)。到目前为止,他们中的许多人还没有任何处方治疗选择。PLENITY的安全性和有效性特性使其非常适合这些个人。它是唯一一种处方体重管理产品,可供体重指数在25公斤/ m2及以上的超重成年人使用,对患有高血压、2型糖尿病或血脂异常或无以上合并症的患者均适用。PLENITY的用于帮助体重管理的时间没有限制。 “ FDA 的批准对于 Gelesis 团队和我们的技术来说是一个重要的里程碑,我们很高兴能够将这一新的处方产品带给数百万寻求安全、有效和方便的治疗方案的人,来管理他们的体重,而不需要手术或兴奋剂。”Gelesis 创始人兼首席执行官Yishai Zohar说道。“有了充足的条件, Gelesis 正在引入一种全新的方法,其独特的作用机制有助于体重管理,其有效性和安全性得到了大型临床研究的积极数据的支持。” 在午餐和晚餐前用带水的胶囊来管理食物的供应。通过将纤维素和柠檬酸这两个自然衍生的建筑块交叉连接起来,可以产生三维水凝胶基质。胶囊释放了数以千计的非聚集性颗粒,这些颗粒能迅速吸收胃中的水分,并产生了具有植物食物(例如蔬菜)弹性(硬度)的小型个体凝胶块,没有热值。凝胶块增加了胃和小肠内容的体积和弹性,有助于感觉饱满和诱导体重减轻。这种新型的、非刺激性的和非系统性的治疗已经在临床研究中被证明是有效、安全和耐受性好的。