| OBSERVATION'S |
A US regulatory decision is expected in the first half of 2007 for Galvus as a once-daily oral treatment for patients with type 2 diabetes. The US Food and Drug Administration (FDA) extended the review period for Galvus by three months from November 2006 after recently available clinical data were submitted to support the proposed dosing and indications as well as complement earlier data on the risk/benefit profile. The additional data being submitted add around 1,000 patient-years of treatment experience with Galvus and include results from short- and long-term studies for periods of up to two years, both as a monotherapy and in combination with other anti-diabetes medicines. The European marketing application for Galvus was filed in August 2006
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