Shares at Switzerland’s Novartis have fallen on an analyst report which suggests that US approval for the company’s new diabetes drug Galvus faces further delays.
Last November, the firm submitted additional information to the Food and Drug Administration showing that reactions affecting the skin, which were seen in preclinical studies of Galvus (vildagliptin), have not been seen in human tests of the drug. This delayed the FDA’s review deadline for the drug by three months, and the agency should delivering a verdict on the application by the end of February.
However, Tim Anderson, an analyst at Prudential Securities, issued a note saying that approval for Galvus, which belongs to the new dipeptidyl peptidase (DPP)-4 inhibitor class, could be delayed beyond that deadline. “This will likely be due to FDA wanting to understand more completely the issue of skin toxicity in primates that has been seen with most DPP-4 inhibitors,” he added. Novartis made no comment on the analyst's note.
Mr Anderson said that any potential delay may only be a matter of months, but time is of the essence for Novartis as there are fears that the company will get left behind by Merck & Co, whose rival drug Januvia (sitagliptin) was approved last October In the fourth quarter, the latter brought $42 million into Merck’s coffers and the company is already filing for new indications for Januvia.