FDA ISSUES APPROVABLE LETTER FOR NOVARTIS' GALVUS APPLICATION
Novartis announced it has received an approvable letter from the FDA for Galvus (vildagliptin), which is being reviewed as a new once-daily oral treatment for patients with Type 2 diabetes.
An approvable letter means the FDA is prepared to approve an investigational medicine but that certain conditions must be met prior to final approval. The FDA has requested additional data, including a clinical study to demonstrate the safety and efficacy of Galvus in specific patient groups with renal impairment.
"We are confident in the safety and efficacy of Galvus and will continue working closely with the FDA to agree on what final actions are required to obtain U.S. approval," James Shannon, the company's global head of development, said.
Novartis originally submitted an application for Galvus in January 2006. Then in November the company announced a three-month extension of the regulatory review period after it decided to submit new clinical data to the FDA.