FDA EXTENDS REVIEW PERIOD FOR NOVARTIS' GALVUS NDA

Novartis has announced a three-month extension in the regulatory review period for its oral diabetes medicine Galvus (vildagliptin) after the company decided to submit newly available clinical data to the FDA. The review period will now extend through February 2007.

The additional data being submitted to the FDA add about 1,000 patient years of treatment experience with Galvus. These data include results from short- and long-term studies for periods of up to two years, both using Galvus as a monotherapy and in combination with other diabetes drugs.

These data further support the proposed dosing regimen and indications as well as the risk-benefit profile for 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 human patients treated for Type 2 diabetes.

Novartis originally submitted its new drug application (NDA) for Galvus in January. 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, according to the company.