Novo Nordisk (NYSE: NVO) reported that Victoza, its once-daily human glucagon-like peptide-1 (GLP-1) analog for type 2 diabetes, was submitted to the SFDA in August of last year. The news came as Novo Nordisk celebrated approval of the product in the US and Japan this week. It has been marketed in Europe since last summer.
In clinical trials, Victoza significantly reduced blood sugar levels, both as a monotherapy and when given along with sulphonylurea (SU), and it also was associated with weight loss.
The product, if approved, will face competition from Byetta, a drug co-developed by Amylin (NSDQ: AMLN) and Lilly (NYSE: LLY), which is also a GLP-1 analog. It is administered twice daily, though a once-weekly version is seeking approval in the US. Lilly, which markets the drug outside the US, was granted SFDA approval of Byetta last August.
All GLP-1 drugs are specified for patients whose type II diabetes is not controlled by other diabetes treatments such as metformin and sulphonylurea.
Victoza stimulates the release of insulin in response to high levels of blood sugar. Novo Nordisk thinks its ability to help patients lose weight is caused by an increase in the feeling of satiety because the drug slows gastric emptying. Other mechanisms may also play a part. Victoza breaks down naturally in the body and does not depend upon renal excretion.