Novo Nordisk’s Ozempic Receives the US FDA’s Approval for the Treatment of Type 2 Diabetes
Shots:
- The approval was based on the P-III (SUSTAIN FORTE trial) evaluating the efficacy & safety of semaglutide (2.0mg) vs semaglutide (1.0mg) as an add-on to metformin or sulfonylureas in 961 patients with T2D
- The results showed that the patients achieved a statistically significant & superior reduction in HbA1c @40wk. & both doses were safe & well-tolerated, gastrointestinal AEs were similar for semaglutide (2.0mg) compared to semaglutide (1.0mg)
- The company is expected to launch Ozempic (2.0mg) in the US in Q2’22 & has been approved in the US, the EU, Canada & Switzerland for the same indication. The therapy is indicated to reduce the risk of major cardiovascular events
Ref: Novo Nordisk | Image: Novo Nordisk
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
