As expected, European regulators have given Novartis full approval to sell its new type 2 diabetes drug Galvus, having accepted the firm’s changes to the prescribing information.
The European Commission has approved Galvus (vildagliptin) in 50mg doses taken either once or twice daily in combination with the most- frequently prescribed anti-diabetes medicines – metformin, thiazolidinedione or sulphonylureas. As announced at the end of the year, when the European Committee for Medicinal Products for Human Use issued a positive opinion on Galvus, a 100mg once-daily dose will now not be available.
Over 20,000 patients have participated in the Galvus clinical trial programme to date, Novartis said, including nearly 13,000 treated with the dipeptidyl peptidase-4 inhibitor. It has “delivered significant blood sugar reductions with a positive tolerability profile in a broad range of patients”, the firm added.
The approval for Galvus in Europe, where analysts believe sales of the drug could reach $400 million, contrasts sharply with the drug’s status in the USA. The US Food and Drug Administration has been less than impressed with Galvus and earlier this year requested more data in an approvable letter which included a demand for another clinical study to demonstrate the safety and efficacy of the treatment in specific patient groups with renal impairment.
This stance has led observers and indeed Novartis to speculate as to whether the drug will ever reach the US market, where Merck & Co’s Januvia (sitagliptin) is still the only DPP-4 inhibitor class to be on the diabetes market. At last month’s annual press conference, chief executive Daniel Vasella said the Basel-based firm is still talking to the FDA but may choose not to pursue US regulatory approval if the agency’s demands for new studies prove excessive.
