This came after the The firm presented the proposal for an update in Package Insert for the drug product Semaglutide Injection 0.25 mg/ 0.5 mg mg/1.7 mg/2.4 mg [Brand name: Wegovy (Single-dose Pen injector)] and Semaglutide Injection 0.25 mg/0.5 mg/1 mg/1.7 mg/2.4 mg [Brand Name: Wegovy FlexTouch] to include updates in Section 4.8—Undesirable effects and Section 5.2—Pharmacodynamic properties based on the results of the conducted clinical trials (STEP HFpEF DM, STEP HFpEF and STEP 9 OA) in line with EMA approved PI.
Wegovy is the brand name for the active ingredient semaglutide when it is used for chronic weight management in adults who are obese or overweight and have at least one weight-related condition (e.g., type 2 diabetes, high blood pressure).
The FlexTouch pen is the delivery device provided by the manufacturer (Novo Nordisk) for injecting the medication subcutaneously (under the skin) once a week.
Semaglutide is a glucagon-like peptide 1 receptor agonist used to improve glycemic control in type 2 diabetes mellitus, treat obesity, and reduce the risk of major adverse cardiovascular events in selected adults.
Semaglutide was developed by Novo Nordisk and approved by the FDA for subcutaneous injection in December 2017. The tablet formulation was approved for oral administration in September 2019. Semaglutide works by binding to and activating the GLP-1 receptor, thereby stimulating insulin secretion and reducing blood glucose.
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GLP-1 is a physiological hormone that promotes glycemic control via several different mechanisms, including insulin secretion, slowing gastric emptying, and reducing postprandial glucagon secretion. The homeostasis of glucose is dependent on hormones such as insulin and amylin, which are secreted by the beta cells of the pancreas. Semaglutide is 94% similar to human GLP-1. Analogs of this hormone, such as semaglutide, stimulate the synthesis of insulin by stimulating pancreatic islet cells and reducing glucagon secretion. They directly bind with selectivity to the GLP-1 receptor, causing various beneficial downstream effects that reduce blood glucose in a glucose-dependent fashion.
At the recent SEC meeting, pharmaceutical major Novo Nordisk submitted a proposal seeking updates to the package insert for Semaglutide Injection 0.25 mg / 0.5 mg / 1 mg / 1.7 mg / 2.4 mg, marketed as
Wegovy® (Single Dose Pen Injector)
Wegovy® FlexTouch®
The updates are based on clinical evidence from trials including STEP HFpEF DM, STEP HFpEF, and STEP 9 OA, aligning the EMA-approved Product Information.
After detailed deliberation, the committee recommended approval of the updated package insert for the proposed changes.
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