Novartis' Galvus gets CHMP thumbs up

Swiss drug major Novartis says that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use has issued a positive opinion recommending the approval of type 2 diabetes treatment Galvus (vildagliptin). The CHMP advised that the drug is cleared for use in combination metformin, a thiazolidinedione or a sulfonyl urea which, the firm notes, is the broadest potential range of indications for any drug in the dipeptidyl peptidase-4 inhibitor class.

The CHMP based its guidance on a review of 13 clinical studies, which included data from more than 5,700 patients. The results showed that Galvus delivered significant blood sugar reductions in patients suffering from type 2 diabetes. In addition, the drug demonstrated a good safety profile with the most frequently reported adverse events including dizziness, headache and stuffy nose.

Galvus, which is currently available in Brazil and Mexico, was the subject of a US Food and Drug Administration second "approvable letter" (Marketletter March 5). In response, Novartis submitted a proposal for several additional studies.