GlaxoSmithKline falls on asthma treatment ruling

Shares in GlaxoSmithKline (GSK) fell more than four per cent on Monday after the US Federal Drugs Administration (FDA) asked the company to add new warnings to the labels of its Serevent and Seretide (marketed as Advair in the US) asthma medications.

GSK disagreed with the ruling, claiming it was inconsistent withy previous National Institutes of Health (NIH) treatment guidelines and the standard of care for asthma treatment.

“Patient safety is of paramount concern to GSK which is why we disagree with the FDA’s proposed labeling changes,” said Dr Kathy Rickard, GSK vice president clinical development and medical affairs, respiratory medicine in the US.

“These proposed labelling 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.”

Seretide and its related drugs account for 15 per cent of GSK’s revenue and analysts suggested the FDA’s move could significantly hamper the British company’s growth prospects in the US.

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