Novartis reports Galvus ‘not as effective as metfromin’

Novartis has announced this week that its treatment candidate for type 2 diabetes is less effective than an older treatment. Trials showed that Galvus (vildagliptin) had lower efficacy than previous drug metformin.

However, the compound exhibited better toleration than the older drug, with specific regard to gastrointestinal tolerability.

Galvus has been submitted to the US regulatory authorities with a decision expected during 2007. Its review period has been extended from November 2006 for three months after the submission of additional clinical data.

Reuters reports this delay as a “setback” though it adds that the company believes that the compound will eventually gain regulatory approval and be an “ideal combination” with the older metformin.

“The main problem here is unless Galvus can show good standalone data, it becomes an add-on and that sort of mediates its potential,” Andrew Fellows, an analyst at Helve, told Bloomberg.

In October, Novartis announced the beginning of the Galiant clinical trial comparing treatment with Galvus with that of standard anti-diabetics known as thiazolidinediones.

The trial involves over 7,500 people and will test for efficacy in providing consistent, sustained and significant lowering of blood sugar levels in patients for enhanced glucose control.