EU regulators have granted a positive opinion to changes made to prescribing information by Novartis for its new diabetes drug Galvus and should be available in the first few months of 2008.

The European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Galvus (vildagliptin) in 50mg doses taken either once or twice daily in combination with anti-diabetes medicines metformin, thiazolidinedione (TZD) or a sulphonylurea. A 100mg once-daily dose will now not be available.

Novartis received European approval in September 2007 for Galvus which did include the 100mg once-daily dose. However last month, the Basel-based firm provided a safety update of pooled data that showed liver enzyme elevations were numerically less frequent in patients taking the 50mg doses compared to the 100mg one.

The European Commission generally follows the CHMP's recommendations and is expected to issue a decision within three months. Then Galvus will take on Merck & Co’s Januvia (sitagliptin), which is still the only treatment in the new dipeptidyl peptidase-4 inhibitor class to be on the diabetes market.

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.
Last November, the firm submitted additional information to the FDA showing that reactions affecting the skin, which were seen in preclinical studies of Galvus have not been seen in human tests of the drug. Novartis is planning to resubmit the drug for review in the USA in 2009.