Galvus, a DPP-4 inhibitor, works through a novel mechanism of action targeting the pancreatic islet dysfunction that causes high blood sugar levels in people with type 2 diabetes. Galvus affects both pancreatic alpha and beta cells, leading to a reduction in sugar production from the liver together with an increase in production of insulin needed to keep blood sugar under control.
Novartis will face stiff competition in this sector as rival Merck & Co. had a similar submission accepted in February this year. Their diabetes drug, Januvia, is also an oral formulation. Furthermore, GlaxoSmithKline and Bristol-Myers Squibb are currently developing similar treatments.
“The prevalence of diabetes is increasing and more than half of the people who are currently taking diabetes medications are still not reaching their blood sugar goals,” said Dr James Shannon, Head of Development at Novartis Pharma AG. “Galvus may represent an exciting new option for the treatment of type 2 diabetes with the potential of helping patients reach and maintain their treatment goals with good tolerability.”
The Novartis submission includes data from clinical trials involving more than 4,300 patients worldwide evaluating the use of Galvus as monotherapy and also in combination with commonly prescribed anti-diabetic agents. Galvus is suitable for once-daily dosing.
Overall, Galvus has shown clinically significant HbA1c reductions out to one year of treatment, with good overall tolerability and without causing weight gain. The most common side effects were cold-like symptoms, headache and dizziness.
Submission for approval of Galvus (vildagliptin, formerly LAF237) in Europe is on track to be completed later in 2006.