Novartis has asked the FDA to extend the review period for its highly anticipated developmental diabetes drug Galvus by three months to allow the agency to examine new clinical trials data.
Novartis said it asked the FDA to consider the new data concerning skin problems in a preclinical animal study of Galvus. The skin problems had not been seen in clinical studies of Galvus to treat Type 2 diabetes patients, Novartis said.
“It was our decision,” a Novartis spokesman told Reuters. “It’s a setback but we are still confident of getting it to the market quickly.”
Novartis’ head of development, James Shannon, added in a statement that the new information being provided to the FDA will “strengthen the already robust data supporting Galvus.” Novartis filed its application with the FDA in January 2006.
Galvus is part of the emerging drug class of DPP-4 inhibitors, which enhance the body's ability to lower elevated blood sugar. Merck was first to market in the class with Januvia, which was approved by the FDA in October.
Analysts have predicted sales of both drugs could reach over $1 billion a year.
Galvus is one of three blockbuster hopefuls for Novartis, along with developmental hypertension drugs Exforge and Tekturna.