GSK EU regulatory update on Pandemrix™

Issued: London UK

GlaxoSmithKline (GSK) today confirmed that on behalf of the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP) has concluded that the available data are insufficient to demonstrate a causal relationship between Pandemrix and the observed cases of narcolepsy. The CHMP has further concluded that any temporary restriction on the use of Pandemrix is not considered warranted.

The CHMP has recommended that all ongoing analyses continue, most notably in Sweden and Finland, where the majority of cases of narcolepsy have been reported. In addition, the CHMP has recommended that the current investigation be expanded to incorporate epidemiological analysis.

The total number of cases of narcolepsy following immunization with Pandemrix reported to GSK as of 0800h GMT on 17 September 2010 was 80, the majority of which were from Sweden and Finland.

“Patient safety is of paramount importance to GSK. In addition to working closely with the regulatory authorities, including EMA, we will also continue our own investigation in an effort to gather additional data and information regarding the reported cases,” said Norman Begg, Chief Medical Officer, GSK Biologicals.

To date, over 30 million doses of Pandemrix have been administered throughout Europe, with the most recent EMA Pharmacovigilance Report¹ (19 August 2010) concluding that the benefit-risk profile of the three centrally-approved H1N1 vaccines, including Pandemrix, continues to be positive.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com

References

¹22nd Pandemic Pharmacovigilance Weekly Update (EMA/527985/2010); 19 August 2010.