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On June 5th, Novo Nordisk announced that the FDA approved Wegovy (Smeglutide 2.
Novo Nordisk submitted a listing application for smeglutide for weight loss indications on December 4 last year.
Obesity is a chronic disease that requires long-term treatment and is associated with many serious health consequences and shortened life expectancy.
The FDA approval is mainly based on data from the Phase IIIa phase of the STEP clinical project.
The STEP 1 study (adjuvant life>The results showed that after 68 weeks of treatment with smeglutide, the intention-to-treat patients lost 16.
STEP 2 study (obese patients with type 2 diabetes) compared the safety of once a week subcutaneous injection of semaglutide 2.
The STEP 3 study (adjuvant intensive behavior therapy) compared the safety and effectiveness of 68-week intensive behavior therapy with a subcutaneous injection of smeglutide 2.
The STEP 4 study (random withdrawal) compared the safety of once a week subcutaneous injection of smeglutide 2.
From the above data, it can be found that once a week subcutaneous injection of smeglutide 2.
Smeglutide was first approved by the FDA on December 5, 2017.
Weight loss drugs are a very large drug market.
So far, GLP-1R agonist weight-loss drugs represented by Saxenda (liraglutide) have accounted for approximately 56% of the global obesity prescription drug market.
In terms of weight loss, Saxenda 3mg treatment for 52 weeks (1 year) can reduce the weight of obese patients without diabetes by 4.
Smeglutide was injected subcutaneously with 2.
However, Eli Lilly’s product pipeline also has another product, tirzepatide (GIP/GLP-1R dual agonist), which is used to counter smeglutide.
Original title: Smegaglutide has been approved by the FDA for weight loss indications! Subcutaneous injection once a week, weight loss 18% in 68 weeks