The Committee for Medicinal Products for Human Use (CHMP) on Friday issued a positive opinion, recommending marketing authorization for a new medication aimed at treating type 2 diabetes mellitus and aiding in weight management.
The product, known as Foundayo, was submitted by Eli Lilly and Co. (NYSE:LLY).
What Is Foundayo?
Foundayo is an oral medication that will be available in several strengths of film-coated tablets, ranging from 0.8 mg to 17.2 mg.
The active ingredient in Foundayo is orforglipron. This substance works as a glucagon-like peptide 1 (GLP-1) receptor agonist.
By acting on these specific receptors in the body, orforglipron helps improve glycemic control and supports weight management through various mechanisms.
Benefits and Potential Side Effects
The primary benefit of Foundayo is its clinically significant impact on glycemic control for individuals with type 2 diabetes.
Additionally, when combined with a healthy diet and regular physical activity, Foundayo has demonstrated a positive effect on body weight.
The most frequently reported side effects associated with the medication are gastrointestinal issues, including nausea, vomiting, and diarrhea.
Approved Uses for Foundayo
Foundayo is indicated for two main purposes in adults.
For weight management, it is intended to be used alongside a healthy diet and physical activity for weight loss and maintenance.
This applies to adults with an initial Body Mass Index (BMI) of 30 kg/m2 or higher (obesity).
It also applies to those with a BMI between 27 kg/m2 and 30 kg/m2 (overweight) if they have at least one weight-related condition, such as prediabetes, type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease.
For type 2 diabetes mellitus, Foundayo is indicated for adults with an insufficiently controlled condition, again as a supplement to diet and exercise.
It can be used as a monotherapy when metformin is not considered appropriate, or in combination with other diabetes medications.
LLY Price Action: Eli Lilly shares were up 1.44% at $1269.60 at the time of publication on Friday. The stock is trading near its 52-week high of $1292.65, according to Benzinga Pro data.
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