The future of Novartis diabetes drug Galvus across the Atlantic looks very uncertain indeed, after the group’s chief executive Dan Vasella said the agent might not be re-filed with US regulators.

Galvus (vildagliptin) was once a hot contender to be the first in a new class of diabetes agents known as DPP-4 inhibitors to make it to market, but has since suffered substantial setbacks on both sides of the pond. Safety concerns over elevated liver enzymes delayed its launch in Europe, but after regulators recently agreed on a lower dosing formulation the group now expects a roll-out there in the next few months.

In the USA, however, the picture looks much less rosy; the Food and Drug Administration has twice asked for additional data on the drug, most recently with regard to its efficacy and safety in patients with renal impairment, and Novartis will have to carry out another clinical study to satisfy the request.

Re-filing originally pencilled for 2009
The company had previously stated its intention to re-file Galvus in 2009 as a result, but, speaking at an earnings call with analysts yesterday, Vasella claimed the FDA had not made it clear exactly what was needed to secure the drug’s approval, and that the group would not start a re-filing process until it had more of an idea of the chance of its success, according to media reports.

The possibility that Galvus may not be entering the US marketplace will certainly put a smile of the face of Merck & Co, who’s rival DPP-4 inhibitor Januvia (sitagliptin) was the first of the new class to hit the market, generating sales of $185 million in the third quarter of last year. The news will also be welcomed by Japan’s Takeda, which has just filed its own DPP-4 inhibitor alogliptin with the FDA.