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Semaglutide: First Global Approval.
1Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.
Drugs
|January 25, 2018
Summary
Novo Nordisk developed a once-weekly subcutaneous semaglutide (Ozempic®) injection for type 2 diabetes. This GLP-1 analogue effectively lowers blood glucose and body weight, receiving recent approvals.
Area of Science:
- Pharmacology
- Endocrinology
- Drug Development
Background:
- Type 2 diabetes mellitus (T2DM) is a global health challenge requiring novel therapeutic approaches.
- Glucagon-like peptide-1 (GLP-1) analogues have emerged as effective treatments for T2DM.
- Semaglutide, a modified human GLP-1 analogue, represents an advancement in T2DM management.
Purpose of the Study:
- To summarize the key development milestones of subcutaneous semaglutide.
- To highlight the journey leading to the first regulatory approval for type 2 diabetes.
- To provide an overview of semaglutide's therapeutic potential.
Main Methods:
- Development of a proprietary protein-acylation technology for semaglutide formulation.
- Administration via a pre-filled, once-weekly injection device (Ozempic® Pen).
- Clinical development encompassing type 2 diabetes, obesity, and liver diseases.
Main Results:
- Successful development of a once-weekly subcutaneous semaglutide formulation.
- Regulatory approvals in the US, Puerto Rico, and Canada for T2DM treatment.
- Positive opinion received in the EU for T2DM treatment.
Conclusions:
- Subcutaneous semaglutide (Ozempic®) offers a new therapeutic option for type 2 diabetes.
- The drug's efficacy in lowering blood glucose and body weight is a significant advancement.
- Ongoing clinical trials suggest broader applications for semaglutide in metabolic diseases.
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