GlaxoSmithKline submits new Seretide data to EU

GlaxoSmithKline (GSK) has submitted new clinical trial data for Seretide, the treatment for asthma and chronic obstructive pulmonary disorder (COPD), with the intention of varying the drug’s label.

The results of the study, entitled TORCH, demonstrated that patients using Seretide demonstrated a 17.5 per cent reduced chance of death from any cause over three years, in comparison to the placebo.

In addition, the number of COPD exacerbations observed for Seretide users was 25 per cent less than with those receiving the placebo.

However, Seretide users experienced a greater number of adverse events classified as lower respiratory tract infections, although GSK claims that this does not “compromise” the greater benefits of using the drug.

Darrell Baker, senior vice president of GSK’s respiratory medicines development centre, remarked: “We believe the results from the TORCH study are clinically important and that they will have a positive impact on the future management of COPD.”

He added that the regulatory authorities were cooperating with the company in modifying the prescribing information to reflect the findings of the new study.

Recently, AstraZeneca has released a number of studies that attempt to demonstrate the superiority of their own asthma and COPD treatment, Symbicort, over Seretide.

Seretide is GSK’s best selling drug, bringing in sales of 822 million pounds during the first quarter of 2006.