FDA's second "approvable letter" requests futher clinical study of Novartis' Galvus

Swiss pharmaceutical major Novartis has received a second "approvable letter" from the US Food and Drug Administration requesting further clinical studies on its oral drug Galvus (vildagliptin), which is under review as a once-daily oral treatment for patients with type 2 diabetes.

The FDA's request prompted analyst at Lehman Brothers to put back their expected launch date for the drug from first-quarter 2008 to as late as early 2009. As a result of the delay, analysts at the firm lowered their US net present value for Galvus from 1.07 Swiss francs per share to 1.00 franc per share, although they have retained a 50% launch probaility for the drug.

The FDA has requested additional data, including a clinical study to demonstrate the safety and efficacy of Galvus in specific patient groups with kidney impairment. Novartis was upbeat about the news. James Shannon, global head of development at the firm, said: "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." The firm said that its 2007 financial outlook issued in January remains unchanged for the group as a whole as well as for the pharmaceutical unit.