Germany’s IQWiG finds no added benefit for Novartis’ Galvus

The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined in a new dossier assessment whether vildagliptin offers an added benefit over the appropriate comparator therapy. Such an added benefit cannot be derived from the new dossier either, however, because the drug manufacturer did not submit any suitable data, the agency said.

Vildagliptin, sold by Swiss pharma giant Novartis (NOVN: VX) under the trade name Galvus or Jalra, has been approved since September 2007 for adults with type 2 diabetes mellitus in whom diet and exercise do not provide adequate glycemic control.

Neither the first dossier assessment from July 2013 nor the assessment of Novartis’ data subsequently submitted from October 2013 resulted in an advantage of vildagliptin for any of the possible therapeutic indications. Referring to results of one further study, which have become available in the meantime, the manufacturer applied to the Federal Joint Committee (G-BA) for a new dossier assessment for the combination with a sulfonylurea.