Novo’s diabetes drug Victoza approved in China
pharmafile | March 16, 2011 | News story | Sales and Marketing | Glucagon-Like Peptide-1, Novo Nordisk, Victoza, diabetes in China, liraglutide, type 2 diabetes
Novo Nordisk’s injectable diabetes drug Victoza has been given regulatory approval in China.
The Chinese State Food and Drug Administration (SFDA) granted it a licence as an add-on to metformin or sulfonylurea in people with type II diabetes.
Diabetes is a rapidly growing disease in China, the manufacturer says, and it expects to launch Victoza (liraglutide)there in the second half of the year.
“The Chinese approval of Victoza represents an exciting opportunity to further advance therapy in people with type 2 diabetes in China,” says Mads Krogsgaard Thomsen, Novo’s chief science officer.
“Victoza offers a unique treatment option by effectively reducing HbA1c and weight with a low risk of hypoglycaemia in people with type 2 diabetes inadequately controlled by oral anti-diabetic agents,” he added.
This has been a very good month for Novo: as well as gaining access to the Chinese market, Victoza also outperformed rival Bydureon, co-developed by Amylin and Alkermes, in a head-to-trial.
Bydureon – which is a once-weekly, as opposed to daily, jab – failed to show non-inferiority to Victoza, the primary endpoint of the trial.
Victoza has also made a strong start to its life on the market, adding nearly DKK 300 million to Novo’s coffers in the second quarter of 2010.
A once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue, the drug works by stimulating the release of insulin from the pancreatic beta cells only when blood sugar levels are high.
Weight loss comes because patients feel fuller after meals, in part because Victoza slows gastric emptying. It is also broken down naturally in the body rather than through renal excretion.
In addition to the US (which gave it the nod in January last year after the FDA agreed post-marketing resrictions), Europe (in mid-2009) and now China, Victoza has also received marketing authorisation in Canada and Japan.
Adam Hill
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