Novartis diabetes drug faces three month delay

Galvus is one of a new class of diabetes drugs known as DPP-4 inhibitors.
Another DPP-4 inhibitor, Merck's Januvia, is ahead in development as it was approved last month.

These recently available data include results from short-and long-term studies for periods of up to two years, both as a monotherapy or in combination with other anti-diabetes medicines.

Novartis commented that the 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, head of development at Novartis Pharma.

The FDA accepted Galvus 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 program is ongoing for Galvus.