US and European approval sought for type 2 diabetes drug semaglutide

Jack Woodfield
Tue, 06 Dec 2016
US and European approval sought for type 2 diabetes drug semaglutide
A new drug which could further improve the treatment of type 2 diabetes has been submitted for approval to be used in America and Europe.

Semaglutide, which helps to moderately stimulate insulin and suppress appetite, has been shown to have positive results on people with type 2 diabetes.

Pharmaceutical firm Novo Nordisk, the developers of semaglutide, has now submitted a New Drug Application (NDA) to the European Medicines Agency (EMA) so it can be used in Europe. Approval has also been sought by the US Food and Drug Administration (FDA).

It February it was reported that the drug, which is a new glucagon-like-peptide-1 (GLP-1) analogue, met its objective in sufficiently lowering HbA1c levels.

In a study involving more than 8,000 people with type 2 diabetes, semaglutide helped to significantly control blood sugar levels and improve weight loss.

A separate study in November also showed that the drug, which is taken once a week, lowered the risk of people with type 2 diabetes developing cardiovascular problems when compared to placebo.

More than 8,000 adults with type 2 diabetes have been involved in the SUSTAIN clinical trial program which has evaluated the efficacy of semaglutide.

Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said the drug had a well tolerated safety profile.

He added: "Achieving blood glucose control, weight loss and reducing the risk of cardiovascular events remains a significant challenge for adults with type 2 diabetes.

"We are excited with this regulatory filing, as results from the SUSTAIN programme show that once-weekly semaglutide has the potential to further improve the treatment of adults with type 2 diabetes."
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