FDA delays approval of Novartis’ Galvus

Novartis said today that the FDA has requested additional data on the drugmaker’s experimental diabetes treatment Galvus, potentially delaying launch of the drug for up to a year. Galvus has been identified by analysts as a potential blockbuster and was one of two key drugs Novartis hoped to launch in 2007. The other is Tekturna, a treatment for high-blood pressure. Galvus and Merck’s Januvia are both part of the emerging drug class of DPP-4 inhibitors, which enhance the body's ability to lower elevated blood sugar. Analysts have predicted sales of over $1 billion for both drugs. The Galvus setback could be a boon for Merck, helping Januvia further gain a foothold in the diabetes drug market. Januvia was approved in October 2006. Fourth quarter sales of the drug came in at $42 million. “This is one of the worst-possible scenarios (for Novartis),” Birgit Kulhoff, a pharmaceutical analyst in Zurich with private bank Rahn & Bodmer, told The Wall Street Journal. “It will extend Merck’s lead by more than a year, meaning that it will be more difficult for Novartis to penetrate the market and it also casts a doubt over Novartis’ outlook, especially for next year, when they expected to return to double-digit sales growth.” Galvus was submitted for FDA 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 Galvus submission is already later than expected. In November, Novartis asked the FDA to extend the Galvus review period by three months to allow the agency to examine clinical trials data concerning skin problems in a preclinical animal study of the drug.