Gospel for diabetics! Novo Nordisk Oral Somaglutide Officially Approved by FDA!

         9Month20On the 2nd, Novo Nordisk took somaglutide tablets (Rybelsus^®) officially acquired the U. S.FDAof marketing approval for combining diet and exercise to improve2Glycemic control in adults with type 2 diabetes. The drug is the first oral glucagon-like peptide approved globally-1(GLP-1) receptor agonist drugs, oral once daily, approved therapeutic doses are7 mgand14 mgIt will be available in the United States in the fourth quarter.

2Type 2 diabetes is the most common form of diabetes, which occurs when the pancreas does not produce enough insulin to keep blood sugar at normal levels.GLP-1It is a normal body hormone that can slow down digestion, prevent the liver from producing too much sugar, and help the pancreas produce more insulin when needed, which has beneficial effects on many important organs including the pancreas, heart and liver. But in2Type 2 diabetes is often found in patientsGLP-1Insufficient level.

Somaglutide belongsGLP-1Receptor agonists.GLP-1The advantages of receptor agonists are that they can effectively control blood sugar, significantly reduce the incidence of hypoglycemia, and significantly reduce the risk of cardiovascular events.2017Year12Month5Day,FDAApproved, the injectable type of Somaglutide is officially listed as a long-acting type.GLP-1Receptor agonists, administered as weekly injections1Times.

Objectively speaking, compared to short-acting injectable hypoglycemic drugs, long-termGLP-1Receptor agonists require only weekly injections1The use of the method reduces the patient's medication pain and improves medication compliance. However, the majority of diabetic patients are still eagerly looking forward to the emergence of oral dosage forms. However, since Somaglutide is a peptide drug, it must face the challenge of degradation of various peptidases in the intestinal tract if it is to achieve oral and intestinal absorption. By combining Somaglutide with a small molecule absorption enhancerSNACcombined to form an oral formula,SNACThe combination allows the absorption of Somaglutide in the stomach, and.SNACThe partial dissolution of can form a relatively high local in the stomach.pHenvironment, thereby increasing the solubility of somaglutide and reducing the degradation of peptidases in the stomach.

The basis for the application for listing and approval of oral Somaglutide is.10ItemPIONEERresults of clinical trials, involving9543ExampleAdult2Type 2 diabetes patients.PIONEERA series of projects“Head to Head”Clinical trials have confirmed:Compared to sitagliptin and endagliflozin,Rybelsus^®Reduces blood sugar levels more effectively. In addition, the useRybelsus^®Treatment achieved up4.4 kgof weight loss. throughoutPIONEERDuring the test,Rybelsus^®It was safe and well-tolerated, with mild to moderate nausea being the most common adverse event, which gradually diminished over time.

New Nordisk'sRybelsus^®It is also currently under review by other registered regulators, including in2019Year4Month26Day to the European Medicines Agency (EMA) submitted oral somaglutide2type diabetes, and in2019Year7To the Japanese Drug and Medical Device Administration (PMDA) submitted a marketing application for oral Somaglutide. In addition, in2019Year3Month20Day alsoFDAsubmittedRybelsus^®(oral semaglutide) for the reduction of adult2Risk of cardiovascular events in patients with type 2 diabetes mellitusNDA, andOzempic^®(Somaglutide Subcutaneous Injection) for reducing adult2New Indications for the Risk of Cardiovascular Events in Type 2 Diabetes MellitusSnda,These two applicationsis expected to be2020Year1Month20day was approved.

AccordingEvaluatePharmaprediction,2024year,GLP-1andSGLT-2will be globallyTOP10Hypoglycemic drugs occupy half of the country. AndAs the world's first oral versionGLP-1Hypoglycemic drugs, whenGlobal sales of oral semaglutideexpectedReach32.3Billions of dollars.

Oral semaglutide, daily only1The second oral administration of the drug, get rid of the inconvenience and psychological torture caused by injection, and at the same time have better than the traditional mainstream drugs to reduce blood sugar and weight loss effect, but alsoreduced the risk of cardiovascular events,Is the gospel of many diabetic patients!