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Submitting a safety update to European regulators, Novartis provided data showing its 100-mg once-daily dose of ?Galvus? (vidagliptin), an oral type 2 diabetes treatment, has more frequent liver enzyme elevations in patients than its already approved 50-mg once- and twice-daily doses.
Basel, Switzerland (Nov. 6)-Submitting a safety update to European regulators, Novartis provided data showing its 100-mg once-daily dose of “Galvus” (vidagliptin), an oral type 2 diabetes treatment, has more frequent liver enzyme elevations in patients than its already approved 50-mg once- and twice-daily doses. As a result, Novartis will seek revisions to prescribing information recommending the lower dose before launching Galvus into European markets.
Current European information recommends a 50-mg once-daily dose in combination with a sulfonylurea, and a 50-mg twice-daily or 100-mg once-daily dose in combination with either metformin or a thiazolidinedione. The new data raises questions whether the company will pull the production of its 100-mg product.
Data analysis was gained from a study of 8000 patients treated with Galvus, which showed that the 0.86% of patients taking the 100-mg once-daily dose had elevations of the liver enzyme aspartate aminotransferase and alanine aminotransferase of greater than three times the upper limit of normal. This percentage was compared with the 0.34% of those taking the 50-mg twice-daily dose and the 0.21% of those taking the 50-mg once-daily dose.
“Novartis will continue working with the Committee for Medicinal Products for Human Use and other agencies to review these results and to revise prescribing information for Galvus,” according to a company statement. The company is also in discussion with the US Food and Drug Administration.