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news.The FDA has proposed a change in the product label for GlaxoSmithKline's asthma medication Advair, which would mean the drug could only be given to asthma sufferers that had not been helped by other medications.
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Adivar, sold as Serevent in Europe, is a major source of revenue for Glaxo, and shares in the company fell almost 5% after the news.
GlaxoSmithKline criticized the decision on the drug, saying that the changes to the label are inconsistent with established National Institutes of Health treatment guidelines and the standard of care for asthma treatment, and could put many patients at risk of uncontrolled asthma.
The FDA decision comes as something of a surprise after an FDA advisory committee meeting held in July 2005 reinforced the favorable benefit-to-risk profile of the medicine. The advisory committee at that time supported the use of long acting beta-agonists in combination with inhaled corticosteroids and proposed no new restrictions.
“These proposed labeling changes would reserve the most effective asthma treatment – the combination of inhaled corticosteroids and long-acting beta agonists – until after a patient has failed on other treatment options and therefore may be at risk for severe outcomes, such as exacerbations and potentially death,” said Dr Kathy Rickard, GSK vice president Clinical Development and Medical Affairs, respiratory medicine in the US.