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Foundayo: US FDA Approves Eli Lilly’s GLP-1 Weight Loss Pill

Foundayo: US FDA Approves Eli Lilly’s GLP-1 Weight Loss Pill

American drugmaker Eli Lilly’s first oral pill for weight loss, Orforglipron, marketed as Foundayo, has been given the green signal by the US Food and Drug Administration (FDA).

Lilly is also known for injectable drugs like Zepbound for obesity and Mounjaro and Trulicity for diabetes. 

Foundayo’s approval comes after the US FDA in December last year approved Novo Nordisk’s Wegovy pill — the first-ever GLP-1 pill for weight loss. The Danish drugmaker rolled out the pill in January this year.

Novo Nordisk was also the first to launch oral GLP 1 Rybelsus to treat type 2 diabetes. It was approved by the US FDA in September 2019.

In a statement, the US FDA said that "Foundayo has been approved for use in combination with a reduced-calorie diet and increased physical activity. The pill is targeted to reduce excess body weight and maintain weight reduction for the long term in adults with obesity or overweight".

Lilly said that the drug will be available from April 6 through its its direct-to-consumer platform LillyDirect at a cost of $149 per month for the lowest dose for self-pay customers — on par with Novo's pill. "Shortly after” it will be available through retail pharmacies and telehealth providers in the US.

"Today, fewer than 1 in 10 people who could benefit from a GLP-1 are taking one, held back by access, stigma, perceived complexity, or the belief that their condition isn't serious enough for treatment. We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications," said David A. Ricks, chair and CEO of Eli Lilly and Company. 

"As a convenient, once-daily oral pill that delivers meaningful weight loss, this is obesity care designed for the real world," he added. 

<h2>Foundayo: A Meaningful Reduction In Body Weight</h2>The US FDA approved Foundayo after two randomized, double-blind, placebo-controlled trials in adults with obesity or with overweight showed benefit.

In these trials, 72 weeks of treatment with Foundayo, in combination with a reduced-calorie diet and increased physical activity, resulted in a statistically significant and clinically meaningful reduction in body weight. 

Deborah Horn, Director of the Center for Obesity Medicine at McGovern Medical School at UTHealth Houston, stated that Foundayo “delivered an average of 12.4 percent weight loss at the highest dose in clinical trials – addressing both the clinical realities of obesity and the practical challenges patients face every day." 

In addition, Foundayo also led to reductions in many markers of cardiovascular risk, including waist circumference, non-HDL cholesterol, triglycerides, and systolic blood pressure across all doses, Eli Lilly said.

Lilly licensed Orforglipron, the main ingredient in Foundayo, from a Japanese pharmaceutical company in 2018. 

As with the injectable forms of GLP-1s, Foundayo is available in six doses, ranging from 0.8mg to 17.2mg. 

In consultation with their doctors, patients start with the lowest dose and gradually work up to higher doses; not everyone may need to reach the highest dose.

Also read: <a href="https://www.healthandme.com/health-wellness/eli-lillys-experimental-glp-1-pill-shows-promising-weight-loss-article-151459744" data-type="tilCustomLink">Eli Lilly's Experimental GLP-1 Pill Shows Promising Weight Loss</a>

Unlike the Wegovy pill, people taking orforglipron do not need to restrict food or drink after taking the pill. Orforglipron is a small molecule that the body can absorb quickly and get into the blood, where it reaches the necessary tissues. 

Foundayo is not safe for use in children and has an increased list of side effects, such as tumors in the thyroid, including thyroid cancer. 

The drugmaker urged watching for possible symptoms, such as 

<ul><li>a lump or swelling in the neck, </li><li>hoarseness, </li><li>trouble swallowing </li><li>shortness of breath.</li></ul>Other common side effects of Foundayo include

<ul><li>nausea, </li><li>constipation, </li><li>diarrhea, </li><li>vomiting, </li><li>indigestion, </li><li>stomach (abdominal) pain, </li><li>headache, </li><li>swollen belly, </li><li>feeling tired,</li><li>belching, </li><li>heartburn, </li><li>gas, </li><li>hair loss.</li></ul>

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American drugmaker Eli Lilly’s first oral pill for weight loss, Orforglipron, marketed as Foundayo, has been given the green signal by the US Food and Drug Administration (FDA). Lilly is also known for injectable drugs like Zepbound for obesity and Mounjaro and Trulicity for diabetes. Foundayo’s approval comes after the US FDA in December last year approved Novo Nordisk’s Wegovy pill — the first-ever GLP-1 pill for weight loss. The Danish drugmaker rolled out the pill in January this year. Novo Nordisk was also the first to launch oral GLP 1 Rybelsus to treat type 2 diabetes. It was approved by the US FDA in September 2019. In a statement, the US FDA said that "Foundayo has been approved for use in combination with a reduced-calorie diet and increased physical activity. The pill is targeted to reduce excess body weight and maintain weight reduction for the long term in adults with obesity or overweight".Lilly said that the drug will be available from April 6 through its its direct-to-consumer platform LillyDirect at a cost of $149 per month for the lowest dose for self-pay customers — on par with Novo's pill. "Shortly after” it will be available through retail pharmacies and telehealth providers in the US."Today, fewer than 1 in 10 people who could benefit from a GLP-1 are taking one, held back by access, stigma, perceived complexity, or the belief that their condition isn't serious enough for treatment. We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications," said David A. Ricks, chair and CEO of Eli Lilly and Company. "As a convenient, once-daily oral pill that delivers meaningful weight loss, this is obesity care designed for the real world," he added. Foundayo: A Meaningful Reduction In Body WeightThe US FDA approved Foundayo after two randomized, double-blind, placebo-controlled trials in adults with obesity or with overweight showed benefit. In these trials, 72 weeks of treatment with Foundayo, in combination with a reduced-calorie diet and increased physical activity, resulted in a statistically significant and clinically meaningful reduction in body weight.   Deborah Horn, Director of the Center for Obesity Medicine at McGovern Medical School at UTHealth Houston, stated that Foundayo “delivered an average of 12.4 percent weight loss at the highest dose in clinical trials – addressing both the clinical realities of obesity and the practical challenges patients face every day." In addition, Foundayo also led to reductions in many markers of cardiovascular risk, including waist circumference, non-HDL cholesterol, triglycerides, and systolic blood pressure across all doses, Eli Lilly said.How Foundayo Works Lilly licensed Orforglipron, the main ingredient in Foundayo, from a Japanese pharmaceutical company in 2018. As with the injectable forms of GLP-1s, Foundayo is available in six doses, ranging from 0.8mg to 17.2mg. In consultation with their doctors, patients start with the lowest dose and gradually work up to higher doses; not everyone may need to reach the highest dose.Also read: Eli Lilly's Experimental GLP-1 Pill Shows Promising Weight Loss Unlike the Wegovy pill, people taking orforglipron do not need to restrict food or drink after taking the pill. Orforglipron is a small molecule that the body can absorb quickly and get into the blood, where it reaches the necessary tissues. Foundayo: Side EffectsFoundayo is not safe for use in children and has an increased list of side effects, such as tumors in the thyroid, including thyroid cancer. The drugmaker urged watching for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing shortness of breath.Other common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired,belching, heartburn, gas, hair loss.

foundayo: us fda approves eli lilly’s glp-1 weight loss pill

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