Analysts say GSK may cut Avandia salesforce numbers

According to analyst reports, GlaxoSmithKline (GSK), the second-largest pharmaceutical company in the world, says it may have to reduce salesforce numbers for its best-selling diabetes drug, Avandia (roseglitazone).

Since a published study said that Avandia presented significant cardiac safety issues, GSK has witnessed a 40 per cent drop in US prescription volume for the drug.

GSK is in the throws of preparing a new US marketing plan for Avandia after the FDA said the drug should carry a cardiac health warning in its revised labelling.

Despite still being available on the US market, industry analysts said that the revised labelling may continue to erode Avandia sales.

Advair Diskus fails to win approvable status
In other negative news, GSK said that the FDA had issued a not approvable letter for the supplemental drug application for the 500/50 strength of Advair Diskus (fluticasone/ salmeterol powder for inhalation) for the treatment of chronic obstructive pulmonary disease (COPD).

The FDA said that it could not see how the Advair 500/50 compared with the existing 250/50 strength in order to allow for appropriate dosing recommendations.

GSK said it was meeting with FDA to discuss the request and thrash out what to do next. This could include a discussion of data GSK recently generated on the reduction of exacerbations with the Advair 250/50 strength.

Dr Katharine Knobil, who is vice-president of respiratory clinical development for COPD at GSK, said: "We are very surprised and disappointed by this FDA decision...the advisory committee voted unanimously that Advair 500/50 demonstrated a significant reduction in the risk of exacerbations. We believe in the strength of the data; this application is based on the results of the largest COPD study conducted in more than 6,000 patients over three years. We are committed to working with the FDA to address any questions they have and to pursue a way forward."