Novartis announced that it has received an “approvable letter” from the US Food and Drug Administration (FDA) for Galvus? (vildagliptin), under review for US approval 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 and contains conditions that must be met prior to final US 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 (kidney) 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 US approval,” said James Shannon, MD, Global Head of Development at Novartis Pharma AG.
The 2007 financial outlook previously communicated in January remains unchanged for the Pharmaceuticals division and for the Group.
Galvus was submitted for US approval in January 2006 as a new therapy to reduce blood sugar levels in patients with type 2 diabetes, both as a monotherapy and in use with other anti-diabetic medicines.
The global clinical trial program to date has included over 8,000 patients, with some 5,500 treated with Galvus. Submission for European U nion approval was made in August 2006.