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Novartis says Galvus lowers blood sugar consistently, no safety risks


Published :
Mon, 25 Jun 2007 07:22
By : Agencies
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ZURICH (Thomson Financial) - Novartis AG said fresh clinical data showed that Galvus delivers consistent and robust blood sugar reductions in patients with type 2 diabetes.

New data on the new once-daily oral treatment confirmed the efficacy and tolerability of Galvus both as a monotherapy and when added to many commonly used diabetes medicines in a range of patients across the type 2 diabetes disease spectrum, the Swiss pharma group said.

In the Galvus clinical program no evidence has been seen of overall weight gain or dangerously low blood sugar levels, side effects commonly associated with some type 2 diabetes medications, Novartis said adding that the overall incidence of side effects was similar to placebo in monotherapy trials.

The US Food and Drug Administration (FDA) had previously asked for more data on Galvus to show its safety and efficacy in patients with kidney impairment.

Novartis said it now expects European regulatory decision by the end of 2007, while discussion in the US are set to continue.

johanna.treeck@thomson.com

jmt/jlc

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