Novartis has announced a three-month extension in the US regulatory review period for the oral anti-diabetes medicine Galvus (vildagliptin) until the end of February 2007 after deciding to submit recently available clinical data to the US Food and Drug Administration (FDA).
These additional data being submitted to the FDA add about 1,000 patients years of treatment experience with Galvus. These recently available data include results from short- and long-term studies for periods of up to two years, both as a monotherapy and in combination with other anti-diabetes medicines.
These new data further support the proposed dosing regimen and indications as well as complement the risk/benefit profile of Galvus. In particular, they provide further evidence confirming data submitted earlier to the FDA showing that skin findings identified in a single species during a preclinical animal study have not been seen in clinical studies with patients treated for type 2 diabetes.
"We are confident of the efficacy and safety of Galvus and in gaining US approval," said James Shannon, M.D., head of development at Novartis Pharma AG. "We believe this additional information being provided to the FDA will strengthen the already robust data supporting Galvus as a new and needed treatment option for patients with type 2 diabetes."
Novartis is committed to working closely with the FDA in its review of Galvus, which the agency accepted for review in March 2006 after Novartis made the filing in January 2006. The FDA has the option of extending the typical 10-month review period for new drugs if a company submits significant additional data during the last three months of the review. An extensive clinical trial programme is ongoing for Galvus.