Correction: Novartis' Galvus
In an article that went on-line yesterday, December 17, we wrongly stated that Novartis' Galvus (vildagliptin) had just been approved by European regulators. In fact, the diabetes drug gained European Union approval in September but the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recently modified its opinion. It now recommends Galvus for use with a sulfonylurea at a 50mg once-daily dose and with metformin or a thiazolidinedione at 50mg twice-daily, with revised labeling to include measures proposed by Novartis to support liver safety of patients taking the drug.
The changes were prompted by new data showing that patients taking the daily 100mg formulation had more frequent liver enzyme elevations than those receiving a 50mg dose of the drug either once, or twice a day. The 100mg once-daily dose of Galvus, which was originally recommended for approval, has been scrapped.
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