Novartis's potential Type II diabetes blockbuster has been given the green light in the EU after receiving approval.
Galvus (vildagliptin), a new once-daily oral treatment for patients with Type II diabetes, has been approved with a broad range of indications for use in combination therapies with other anti-diabetic medicines for 27 countries of the EU.
The Swiss company had been anticipating the approval of the drug since July when the Committee for Medicinal Products for Human Use (CHMP) gave Galvus a positive opinion.
Just last week, the committee also recommended for approval the company's Eucreas, a single tablet combination of Galvus and metformin for the treatment of Type II diabetes.
The positive uptake of Galvus in Europe comes eight months after US regulators issued an approvable letter to the company requesting additional data before making a final approval on the product, including a clinical study to demonstrate the safety and efficacy of Galvus in specific patient groups with renal impairment.
With the initial submission for approval in the US in January last year, this new request for additional information would now mean Galvus would not be ready for resubmission until mid-2009.
But Novartis has remained confident and is working towards the drug's approval.
Meanwhile, the approval in Europe would give patients an alternative treatment option for Type II diabetes because of the unique action of Galvus.
A member of a new class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors, Galvus works through a novel mechanism of action by targeting the dysfunction in the pancreatic islets that cause high blood sugar levels in people with Type II diabetes.
Galvus is an attractive option as it lowers blood sugar levels with no weight gain and a low incidence of hypoglycaemia, which are two of the side effects often seen in the use of some of the other treatments for diabetes.
"We are delighted that Galvus is approved in Europe for patients with Type II diabetes," Novartis global head of development James Shannon said in a statement.
"Our rigorous clinical trial programme has demonstrated the robust efficacy and tolerability of Galvus, which offers versatility to physicians looking for new treatment options."
The EU approval allows Galvus to be used in combination with some of the most frequently prescribed oral anti-diabetes medicines, including metformin, sulfonylureas, and thiazolidinediones.
Studies show Galvus "delivers significant blood sugar reductions when used in combination with the most commonly used oral diabetes medicines" and is well tolerated in a broad range of patients with Type II diabetes.
A fortnight ago, Merck released combination therapy data in regards to its diabetes DPP-4 inhibitor Januvia (sitagliptin), which has already been approved in the US. As an initial therapy in combination with metformin, Januvia provided significant and sustained improvement in blood sugar control compared to metformin alone and was generally well tolerated over a one-year period, the US company said.
Approximately 28 million people in developed countries have Type II diabetes.