Novartis Recommends Against Its High-Dose Diabetes Drug

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ePT--the Electronic Newsletter of Pharmaceutical Technology

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.

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“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.