GlaxoSmithKline hit by FDA proposal

GlaxoSmithKline (GSK) shares fell by around five percent to £14.24 last night (21 November) following the US FDA's (Food and Drug and Administration) proposed restrictions on its asthma drug Advair, sold as Seretide in Europe, stating that it should not be given as a first-line treatment.

The announcement came after a clinical study showed that drugs containing long-acting beta agonists (LABAs), such as Advair, can trigger severe asthma attacks and, consequently, cause death.

The warnings also cover GSK's Serevent, the LABA component of Advair, which is sold as a separate medicine for the maintenance treatment of asthma and the prevention of bronchospasm, as well as Novartis' Foradil, and could threaten two other drugs awaiting approval in the US: AstraZeneca's Symbicort and Novartis' QAB, both of which contain a LABA.

Advair was GSK's best-selling product in 2004 generating worldwide sales of £3.43bn, with £1.71bn coming from the US. It is indicated for long-term, twice-daily, maintenance treatment of asthma in aged four years plus. The restrictions could threaten future sales and growth of the drug in the US, where, according to GSK, it has filled 81.9 million prescriptions.

GSK has released a statement saying that it 'disagrees with the FDA's proposed product labeling changes because they are inconsistent with established NIH (National Institutes of Health) treatment guidelines and the standard of care for asthma treatment.

'The proposed changes are a departure from recent outcomes of a July 2005 FDA advisory committee meeting that reinforced the favourable benefit-to-risk profile of both medicines. The advisory committee supported the use of LABAs in combination with inhaled corticosteroids (ICS) and proposed no new restrictions. Since that time, there have been no new data on the safety or efficacy about salmeterol used alone or in combination with ICS.'

In other news, an application by Canadian company ID Biomedical, an integrated biotechnology company focused on the development of innovative vaccine products, to the British Columbia Supreme Court for approval of its proposed acquisition by GSK has been rescheduled to 2 December 2005.