Novartis has received a positive opinion recommending European Union approval of Galvus (vildagliptin) as a new once-daily oral medication for type 2 diabetes, a disease affecting an estimated 28 million patients in Europe.
The Committee for Medicinal Products for Human Use (CHMP), which reviews medicines for the European Commission, issued the positive opinion based on data from more than 5,700 patients in 13 clinical studies.
According to a Novartis press release, the company so fare has received a total of seven product approvals and four positive opinions from the US and European regulatory authorities, providing innovative treatments to patients and creating a strong new growth platform.
The European Commission generally follows the CHMP's recommendations and is expected to issue a decision on Galvus within three months. The decision will apply in all 27 EU member states plus Iceland and Norway.
The clinical trial program showed that Galvus delivered significant blood sugar reductions in a range of patients with type 2 diabetes. Furthermore, Galvus provided additional efficacy when added to the most commonly used oral diabetes medicines.
Galvus is recommended in the EU for use in combination with the most common oral diabetes medicines - metformin, a thiazolidinedione (TZD) or a sulfonylurea (SU) - the broadest proposed indication for any member of the new DPP-4 inhibitor class of drugs.
When studied in combination with the most widely-used diabetes medicines, Galvus showed a positive safety and tolerability profile. The most frequent side effects seen in the Galvus clinical programme were stuffy nose, headaches and dizziness.
"Galvus is an important new treatment option for controlling type 2 diabetes because it provides beneficial blood sugar reductions without many of the side effects seen with other diabetes medications," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "Many type 2 diabetes patients need more than one treatment to bring their blood sugar levels under control, therefore the efficacy and tolerability of Galvus in combination with other medicines is especially significant."
More than 21,000 patients have participated in the Galvus clinical trial program to date, including approximately 10,000 treated with Galvus. The recommended dose of Galvus is 100 mg once-daily when used in combination with metformin or a TZD, and 50 mg once-daily in combination with an SU.
"The positive opinion and recommended label in Europe reflect the depth and breath of preclinical and clinical data for vildagliptin as one of the most widely studied DPP-4 inhibitors," said Bo Ahren, MD, Head of the Research Department at Lund University Hospital, Sweden. "The clinical trial program has shown vildagliptin to be safe, effective and well tolerated across a range of patients. This new treatment option has the potential to make a difference for the many millions of patients who suffer from type 2 diabetes and are still not achieving their blood sugar goals using existing treatments."
Galvus is available in Brazil and Mexico. In February 2007, Novartis received an "approvable letter" from the US Food and Drug Administration. Novartis has submitted a proposal to the FDA for additional studies in renally impaired patients to also confirm good tolerability in this patient group. Skin lesions, as seen in monkeys, have not been seen either in healthy volunteers or in patients in the Galvus clinical trial program involving clinical studies lasting up to two years.
As a member of the new class of DPP-4 inhibitors, Galvus works through a novel mechanism of action by targeting the dysfunction in the pancreatic islets that causes high blood sugar levels in people with type 2 diabetes. Islet dysfunction, along with insulin resistance, is a contributory factor to type 2 diabetes, a progressive disease in which control of blood sugar deteriorates over time.