After 7 years of no approval for anti obesity drugs FDA has recently approved Novo nordisk semaglutide for the treatment of obesity. Semaglutide has been approved in 2017 for use in type 2 diabetes. It has generated sales of nearly 3.4 billion dollars.
Semaglutide was launched by the brand name Ozempic.
STEP Clinical trial program
FDA has approved this drug glutide as anti obesity drugs after rigorous clinical trial by Novo nordisk named as STEP program.
This drug was found to be effective to reduce the weight loss in obese patient and in patient with type 2 diabetes and other comorbidities.
STEP was a double blind randomised control trial. It has achieved the endpoints and seems promising in weight loss.
The drug was studied in overweight and obese patients and compared with placebo. It was also studied with lifestyle modification and was found to be effective compared to placebo.
This study was done for the doses 2.4 mg and 1 mg and was studied over 68 weeks of use.
What is semaglutide?
Semaglutide is a drug used to treat type 2 diabetes mellitus. It acts like the hormone GLP1. It acts on glp 1 receptors.
Glp 1 are drugs used in treatment of type 2 diabetes mellitus for the better control of the blood sugar. Glp is a short form of glucagon-like peptide. Glp 1 is an incretin hormone that has the ability to reduce blood sugar levels. Glp 1 hormone acts on glp 1 receptors for the hormone.
Semaglutide mimics glp 1 hormone in a way it acts on glp 1 receptors similar to glp 1 hormone. It reduces blood sugar level by its action on glp 1 receptors.
It helps for better control of blood sugar. Thus it is useful in type 2 diabetes. It has a long half life of 68 hours and it is active for 7 days when administered.
What are some other drugs that act on GLP-1 receptors?
Diabetes drugs in the GLP-1 agonists class include:
- Dulaglutide (Trulicity), taken by injection weekly
- Exenatide extended release (Bydureon), taken by injection weekly
- Exenatide (Byetta), taken by injection twice daily
- Semaglutide (Ozempic), taken by injection weekly
- Semaglutide (Rybelsus), taken by mouth once daily
- Liraglutide (Victoza), taken by injection daily
- Lixisenatide (Adlyxin), taken by injection daily
What is the benefit of semaglutide over other drugs?
The benefit of semaglutide over other drugs is its long half life. It has prolonged action of 7 days once the dose is given. So it can be used once a week. This picture makes it very comfortable for taking the drug.
Currently the data of studies have shown that this drug reduces weight when used over 68 weeks in doses 2.4 mg.
How is this anti obesity drug administered?
This drug is administered subcutaneously like insulin injection. Subcutaneous dose of 2.4 MG was studied in an STEP trial over 68 weeks.
Currently this drug is started as a 0.25 mg dose and over a period increased slowly after every 4 weeks.
What are the side effects of semaglutide?
Semaglutide, like any other medicine, has side effects. The common side effects of semaglutide are as follows:
- Nausea and vomiting
- Loose motions
- Abdominal pain
- Acid reflux
Some serious thyroid tumors and effects on kidneys. Worsening of diabetic retinopathy was one of the side-effects noted.
What will be the brand name of this drug?
The brand name of this drug will be Wegovy. It will soon be launched in the market by Novo nordisk.
When will this drug be available in the market?
Wegovy will be available in the market later this month according to Novo nordisk’s declaration.
For whom semaglutide has been approved for use by the FDA?
FDA has approved semaglutide subcutaneous injection for use in obese patient with BMI 30 and above. FDA has also approved use of semaglutide subcutaneous injection in people with BMI more than 27 with one or more weight related complications like high blood pressure and type 2 diabetes.
Is it available as an oral drug?
According to Novo Nordisk, a more convenient oral form of the drug is currently under study for use as anti obesity drugs. Oral form of drug is yet not approved for use as anti obesity drugs by FDA. So currently only the subcutaneous injection is approved for use as an anti obesity drug.
What will be the price of Wegovy?
The price of this new brand, yet has not been disclosed.