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Delayed Galvus cleared for 2008 European launch

Published on 19/12/07 at 02:09pm

A key European regulatory committee has approved revised labelling for Novartis' diabetes drug Galvus, paving the way for a 2008 launch.

The drug's launch was delayed after liver safety concerns emerged last month, forcing Novartis to ask the Committee for Medicinal Products for Human Use to look again at its prescribing information.

The European Commission generally follows CHMP recommendations, and Novartis expects a decision within three months setting it up to launch Galvus in the first half of 2008.

The CHMP recommended Galvus for use with a sulfonylurea at a 50-mg once-daily dose and with metformin or a thiazolidinedione at a 50-mg twice-daily dose, but the 100-mg dose included in the drug's September approval has been scrapped.

The new recommendation also states Galvus should not be given to patients with liver impairment, and liver monitoring should be conducted at the start of treatment, every three months for the first year, and then periodically thereafter.

In November a new analysis of clinical data showed a liver side effect was more common in some doses of Galvus.

The updated analysis of pooled clinical trial data involved more than 8,000 patients receiving Galvus and shed further light on a known imbalance in liver enzyme levels, which can indicate liver cell damage.

The results showed 0.86% of Galvus patients taking the 100-mg once-daily dose, 0.34% of those taking the 50-mg twice-daily dose and 0.21% of those taking the 50-mg once-daily dose had levels of liver enzymes more than three times normal upper limits.

At a 50-mg daily dosage, the incidence rate was comparable to the 0.20% seen in the pooled comparator group of about 4,400 patients taking an older diabetes drug - metformin, a glitazone or a sulfonylurea - or a placebo.

The delay and safety doubts may have given Merck's rival drug Januvia more time to establish itself. Januvia is in the same new DPP-4 inhibitor class as Galvus, but has been free of safety concerns so far.

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