Novartis’ diabetes drug, Galvus, is one step closer to approval in the European Union after an EU advisory committee issued a positive opinion on the drug.
Galvus is a once-daily oral medicine for patients with type 2 diabetes. The company reports that Galvus significantly reduced blood sugar levels in people age 65 and older without the increased risk of side effects that often limits more aggressive treatment in these patients.
Galvus is awaiting FDA approval in the United States, where the agency has twice delayed approval of Galvus pending further data to show that skin lesions and kidney impairments seen in an earlier animal study have not occurred in humans.
A similar drug called Januvia is marketed by Merck, and was approved by the FDA in October 2006.
Recommendations by the European Committee for Human Medicinal Products usually lead to approval of the drug for sale in all the European Union countries, and Novartis indicated that it expects a final decision within the next 90 days.