Galvus gets positive opinion from CHMP

Swiss drug major 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.

This announcement came on the same day that the CHMP recommended approval for two other Novartis medicines: Aclasta (zoledronic acid 5mg) for postmenopausal osteoporosis; and Exelon (rivastigmine transdermal patch) for Alzheimer's disease. So far this year, the firm has received a total of seven product approvals and four positive opinions from US and European regulatory authorities.

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, Novartis noted.