A three-month extension until the end of February has been granted in the FDA’s review period for Novartis AG’s oral anti-diabetes medicine Galvus (vildagliptin).
The extension followed submission of additional clinical data representing about 1,000 patient-years of treatment experience with the drug, both as a monotherapy or in combination with other diabetes agents. The company said the new data provided confirmation of earlier evidence showing that skin findings that emerged during a preclinical animal study have not been seen in clinical studies with type 2 diabetes patients.
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“We believe this additional information being provided to the FDA will strengthen the already robust data supporting Galvus as a new and needed treatment option for patients with type 2 diabetes,” said James Shannon, MD, head of development at Novartis Pharma AG.
