Another blow for GSK!!
Posted by shutah on May 6, 2007
PharmaTimes 2 May 2007 – ADVAIR – “asthma blockbuster”
GlaxoSmithKline has not received the full backing it was hoping for from a US regulators’ panel to support its view that the highest dose of its asthma blockbuster Advair Diskus can increase survival rates for patients with chronic obstructive pulmonary disease.
This is a blow for GSK which had submitted data from three clinical trials to the FDA in support of the new indication for Advair, including the landmark study TORCH which involved over 6,110 patients. TORCH showed a 2.6% improvement in survival over three years among patients receiving Advair compared to placebo, but the FDA said that when looking at the USA alone, the survival benefit was 1.6%.
Advair is GSK’s best-selling drug, with first-quarter revenues reaching £835 million (+11%) and this figure would be boosted if expanded use were granted.
Sounding at all familiar ???